This page shows what was measured, who it was measured in, and what that does not settle.
What Brivaracetam does in the body
Focal (partial-onset) epilepsy
Nerve endings store their chemical messengers in tiny bubbles and release them when the cell fires. Brivaracetam gets inside those bubbles and binds a protein in their wall called SV2A, the same protein levetiracetam binds, but it holds on roughly twenty times more tightly and enters brain tissue faster. When firing becomes rapid and repetitive, as in a seizure, less messenger is released, so the burst is less able to build and spread.
What happened in people
Somnolence and fatigue-related reactions in 25% against 14% on placebo, rising from 20% to 27% across the dose range
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
Brivaracetam United States prescribing information: Clinical Studies 14 and Table 6, Warnings and Precautions 5.1 to 5.6, Drug Abuse and Dependence 9.1 and 9… · a recorded source, not a stored snapshot
Levetiracetam United States prescribing information, Warnings and Precautions 5.1, used here only for the behavioural adverse reaction rates quoted in compar… · a recorded source, not a stored snapshot
Used largely as an escape route from levetiracetam behavioural effects, a use its trials were not designed to test
Where it acts
Presynaptic nerve terminal, at the synaptic vesicle membrane in cortex and hippocampus
Kind of result
Symptoms and quality of life
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · U863JGG2IA · read 2026-08-29
Its recorded molecular formula is C11H20N2O2, weighing 212.29.
US prescribing information · 41e218af-048b-4e24-91d2-0b9b262d480c · read 2026-08-30
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 97 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Percent reduction in 7-day partial-onset seizure frequency over placebo, at 50 mg/day and 100 mg/day
✗ The study did not show it
Who was studied
Brivaracetam adjunctive Study 1 (label Clinical Studies 14, Table 6)
9.5% at 50 mg/day and 17.0% at 100 mg/day over placebo; neither carries the significance marker the label applies at alpha 0.05
Repeated elsewhere
Failed to Replicate
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Approximately 20% of patients in this study were on concomitant levetiracetam, and the label states brivaracetam provided no added benefit when added to it.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, oral solution and intravenous injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Brivaracetam United States prescribing information: Clinical Studies 14 and Table 6, Warnings and Precautions 5.1 to 5.6, Drug Abuse and Dependence 9.1 and 9… · a recorded source, not a stored snapshot
Levetiracetam United States prescribing information, Warnings and Precautions 5.1, used here only for the behavioural adverse reaction rates quoted in compar… · a recorded source, not a stored snapshot
Drugs@FDA: BRIVIACT (brivaracetam) tablets, NDA 205836, original approval 18 February 2016; oral solution NDA 205837; injection NDA 205838 (https://www.acces… · a recorded source, not a stored snapshot
Percent reduction in 7-day partial-onset seizure frequency over placebo, at 50 mg/day
✓ The study showed what it set out to show
Who was studied
Brivaracetam adjunctive Study 2 (label Clinical Studies 14, Table 6)
16.9% reduction over placebo, statistically significant at alpha 0.05
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The same 50 mg/day dose produced 9.5% over placebo and missed significance in Study 1, so the two results sit either side of the threshold at similar effect sizes.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, oral solution and intravenous injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Brivaracetam United States prescribing information: Clinical Studies 14 and Table 6, Warnings and Precautions 5.1 to 5.6, Drug Abuse and Dependence 9.1 and 9… · a recorded source, not a stored snapshot
Levetiracetam United States prescribing information, Warnings and Precautions 5.1, used here only for the behavioural adverse reaction rates quoted in compar… · a recorded source, not a stored snapshot
Drugs@FDA: BRIVIACT (brivaracetam) tablets, NDA 205836, original approval 18 February 2016; oral solution NDA 205837; injection NDA 205838 (https://www.acces… · a recorded source, not a stored snapshot
Percent reduction in 28-day partial-onset seizure frequency over placebo, at 100 mg/day and 200 mg/day
✓ The study showed what it set out to show
Who was studied
Brivaracetam adjunctive Study 3 (label Clinical Studies 14, Table 6)
25.2% at 100 mg/day and 25.7% at 200 mg/day over placebo, both statistically significant at alpha 0.05
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Patients on concomitant levetiracetam were excluded from this study, the only one of the three to exceed 25% reduction over placebo, though about 54% had prior levetiracetam exposure.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral tablet, oral solution and intravenous injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Brivaracetam United States prescribing information: Clinical Studies 14 and Table 6, Warnings and Precautions 5.1 to 5.6, Drug Abuse and Dependence 9.1 and 9… · a recorded source, not a stored snapshot
Levetiracetam United States prescribing information, Warnings and Precautions 5.1, used here only for the behavioural adverse reaction rates quoted in compar… · a recorded source, not a stored snapshot
Drugs@FDA: BRIVIACT (brivaracetam) tablets, NDA 205836, original approval 18 February 2016; oral solution NDA 205837; injection NDA 205838 (https://www.acces… · a recorded source, not a stored snapshot
What we know
RNAWiki holds 3 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Brivaracetam
What a person takes: Oral tablet, oral solution and intravenous injection.
The measurement behind this step
The absence of a titration period is the distinctive practical feature: the starting dose is a therapeutic dose, so the drug can be brought in during a hospital admission and works from the first day. The intravenous form allows the same dose without conversion, which is why brivaracetam appears in acute settings despite having no status epilepticus indication.
Getting in
Swallowed or infused, started at a full dose on day one
Absorption is rapid and complete, and unlike most anti-seizure drugs there is no build-up period. The starting dose is a therapeutic dose, which is convenient and also means side effects arrive immediately.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Oral bioavailability approaches complete absorption and the registration trials used no titration period at all. Metabolism proceeds mainly by hydrolysis of the amide group and by CYP2C19-mediated hydroxylation, with no meaningful induction or inhibition of other enzymes, so the interaction burden is minimal. The intravenous form allows the same dose without conversion.
Brivaracetam United States prescribing information: Clinical Studies 14 and Table 6, Warnings and Precautions 5.1 to 5.6, Drug Abuse and Dependence 9.1 and 9… · a recorded source, not a stored snapshot
Levetiracetam United States prescribing information, Warnings and Precautions 5.1, used here only for the behavioural adverse reaction rates quoted in compar… · a recorded source, not a stored snapshot
It enters brain tissue faster than its predecessor
The added propyl group makes the molecule more fat-soluble, so it crosses into the brain more quickly and reaches nerve endings sooner after a dose.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Higher lipophilicity than levetiracetam produces faster brain penetration. The relevant compartment is the presynaptic terminal, where SV2A sits in the synaptic vesicle membrane at roughly the same copy number as synaptophysin.
Brivaracetam United States prescribing information: Clinical Studies 14 and Table 6, Warnings and Precautions 5.1 to 5.6, Drug Abuse and Dependence 9.1 and 9… · a recorded source, not a stored snapshot
Levetiracetam United States prescribing information, Warnings and Precautions 5.1, used here only for the behavioural adverse reaction rates quoted in compar… · a recorded source, not a stored snapshot
It binds SV2A from inside the vesicle, about twenty times more tightly
The target sits on the inner face of the storage bubble, so the drug reaches it only when a bubble opens to release its contents and reseals. Brivaracetam holds that target far more tightly than levetiracetam does.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The label describes high and selective affinity for SV2A and states that the precise mechanism of anticonvulsant activity is not known. The binding site is luminal, requiring vesicle exocytosis and endocytosis for access, which makes target engagement use-dependent. The label separately records that adding brivaracetam to levetiracetam produced no added benefit, which is the clinical shadow of two ligands competing for one site.
Brivaracetam United States prescribing information: Clinical Studies 14 and Table 6, Warnings and Precautions 5.1 to 5.6, Drug Abuse and Dependence 9.1 and 9… · a recorded source, not a stored snapshot
Levetiracetam United States prescribing information, Warnings and Precautions 5.1, used here only for the behavioural adverse reaction rates quoted in compar… · a recorded source, not a stored snapshot
A nerve ending firing slowly is barely affected. One firing in a fast burst releases progressively less messenger, so the burst does not build or spread.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
SV2A engagement reduces vesicle release probability during sustained high-frequency trains with little effect on single evoked responses. The step SV2A actually controls, whether priming, calcium-dependent fusion or something else, remains contested, and the label declines to specify it.
Brivaracetam United States prescribing information: Clinical Studies 14 and Table 6, Warnings and Precautions 5.1 to 5.6, Drug Abuse and Dependence 9.1 and 9… · a recorded source, not a stored snapshot
Levetiracetam United States prescribing information, Warnings and Precautions 5.1, used here only for the behavioural adverse reaction rates quoted in compar… · a recorded source, not a stored snapshot
About a quarter more seizure reduction than placebo, with a flat top end
In the largest trial, 100 mg a day cut seizures 25.2% more than placebo and 200 mg a day cut them 25.7% more. In the first trial neither 50 nor 100 mg separated from placebo at all.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Efficacy is established across three fixed-dose placebo-controlled trials in 1,550 patients with refractory focal epilepsy, two of which met significance. The dose-response is flat between 100 and 200 mg/day, and no benefit was observed when brivaracetam was added to levetiracetam. No active-comparator or monotherapy trial exists.
Brivaracetam United States prescribing information: Clinical Studies 14 and Table 6, Warnings and Precautions 5.1 to 5.6, Drug Abuse and Dependence 9.1 and 9… · a recorded source, not a stored snapshot
Levetiracetam United States prescribing information, Warnings and Precautions 5.1, used here only for the behavioural adverse reaction rates quoted in compar… · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
People with focal epilepsy from one month of age, often those who could not tolerate levetiracetam behavioural effects. It has an intravenous form and essentially no interaction burden.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness in pediatric patients below the age of 1 month have not been established.”
US prescribing information · 41e218af-048b-4e24-91d2-0b9b262d480c · read 2026-08-30
On older people, the label states: “There were insufficient numbers of patients 65 years of age and older in the double-blind, placebo-controlled epilepsy trials (n=38) to allow adequate assessment of the effectiveness of brivaracetam in this population.”
US prescribing information · 41e218af-048b-4e24-91d2-0b9b262d480c · read 2026-08-30
On people who are pregnant, the label states: “Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as brivaracetam, during pregnancy.”
US prescribing information · 41e218af-048b-4e24-91d2-0b9b262d480c · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Data from published literature indicate that brivaracetam is present in human milk.”
US prescribing information · 41e218af-048b-4e24-91d2-0b9b262d480c · read 2026-08-30
On people with reduced liver function, the label states: “Because of increases in brivaracetam exposure, dosage adjustment is recommended for all stages of hepatic impairment [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ] .”
US prescribing information · 41e218af-048b-4e24-91d2-0b9b262d480c · read 2026-08-30
On people with reduced kidney function, the label states: “Dose adjustments are not required for patients with impaired renal function.”
US prescribing information · 41e218af-048b-4e24-91d2-0b9b262d480c · read 2026-08-30
Where the result stopped carrying
Study 1, the first pivotal trial, missed significance at both doses tested
The add-on-to-levetiracetam subgroup showed no benefit, which is the closest thing the programme contains to a direct test of its own premise
The dose-response curve is flat between 100 and 200 mg/day, so the top of the range buys side effects rather than seizure control
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Given by a clinician
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral tablet, oral solution and intravenous injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
The absence of a titration period is the distinctive practical feature: the starting dose is a therapeutic dose, so the drug can be brought in during a hospital admission and works from the first day.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold. The rest of the recorded wording: The intravenous form allows the same dose without conversion, which is why brivaracetam appears in acute settings despite having no status epilepticus indication.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
No boxed warning. Somnolence and fatigue-related reactions occur in 25% of patients on at least 50 mg/day against 14% on placebo, rising with dose; dizziness and gait disturbance in 16% against 10%; psychiatric reactions including psychotic symptoms, irritability, depression, aggression and anxiety in about 13% against 8%. Hypersensitivity with bronchospasm and angioedema requires permanent discontinuation. Serious dermatologic reactions are labelled. Withdrawal must be gradual. It is a Schedule V controlled substance. The class-wide suicidality warning applies: 0.43% against 0.24% across 199 pooled placebo-controlled trials of 11 anti-seizure drugs, adjusted relative risk 1.8 (95% CI 1.2 to 2.7).
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Where this came from
Brivaracetam United States prescribing information: Clinical Studies 14 and Table 6, Warnings and Precautions 5.1 to 5.6, Drug Abuse and Dependence 9.1 and 9… · a recorded source, not a stored snapshot
Levetiracetam United States prescribing information, Warnings and Precautions 5.1, used here only for the behavioural adverse reaction rates quoted in compar… · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral tablet, oral solution and intravenous injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
The intravenous form allows the same dose without conversion, which is why brivaracetam appears in acute settings despite having no status epilepticus indication.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
79 products list this as an active ingredient in the United States drug directory. 79 of them contain it and nothing else.
FDA National Drug Code directory · 72205-272 · read 2026-08-29
They are sold as injection, injection, solution, injection, suspension, powder, solution and tablet, taken intravenous and oral.
FDA National Drug Code directory · 72205-272 · read 2026-08-29
The regulator's established pharmacologic class for it is epoxide hydrolase inhibitors [moa].
FDA National Drug Code directory · 72205-272 · read 2026-08-29
22 published labels name it as an active ingredient. 22 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 41e218af-048b-4e24-91d2-0b9b262d480c · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 41e218af-048b-4e24-91d2-0b9b262d480c · read 2026-08-29
Brivaracetam is oral at 3 DOSAGE FORMS AND STRENGTHS 50 mg tablets: Light orange to orange, oval shaped, film-coated tablets debossed with “IT” on one side and “50” on other side. 100 mg tablets: Light pink to pink, oval shaped, film-coated ta…, recorded as fda label in effect 2026-07-14 in the United States.
US prescribing information · 41e218af-048b-4e24-91d2-0b9b262d480c · read 2026-08-30
Recorded price in US: 0.18721–0.26344 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 21 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Recorded price in US: 0.26378 USD per one millilitre, across 5 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Brivaracetam studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That twenty-fold higher SV2A affinity produces a clinically stronger drug, when the one head-to-head circumstance available showed no added benefit on top of levetiracetam
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That brivaracetam avoids levetiracetam behavioural effects, when no randomised comparison exists and brivaracetam carries its own 13% against 8% placebo-controlled rate
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That it is interchangeable with or preferable to any other anti-seizure drug, when every efficacy number it holds is against placebo in refractory add-on use
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That 200 mg/day is a stronger dose worth reaching for, when it beat 100 mg/day by 0.5 percentage points while adding somnolence
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Brivaracetam are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
The first pivotal trial failed at both doses
In plain words
Study 1 compared 50 and 100 mg a day against placebo in 299 patients. Seizure frequency fell 9.5% and 17.0% more than on placebo, and neither figure reached statistical significance.
What was measured
Percent reduction in partial-onset seizure frequency over placebo, by study and dose, with significance markers
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The label reports the primary efficacy outcome of all three pivotal studies in a single table, with an asterisk marking statistical significance at alpha 0.05. In Study 1, percent reduction in 7-day partial-onset seizure frequency over placebo was 9.5% at 50 mg/day (n=99) and 17.0% at 100 mg/day (n=100) against placebo (n=100), and neither carries the significance marker. Study 2 tested 50 mg/day alone and reached 16.9% over placebo, marked significant. Study 3 tested 100 and 200 mg/day in a much larger sample and reached 25.2% (n=252) and 25.7% (n=249) over placebo (n=259), both significant. Two of the three studies therefore succeeded, and the dose that failed in Study 1 succeeded in Study 2 at almost the same effect size, which is what an underpowered negative result looks like. The label presents all three without commentary on the discrepancy.
Source
Brivaracetam United States prescribing information, Clinical Studies 14, Table 6 (openFDA drug label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Added to levetiracetam, it provided no added benefit
In plain words
About one in five patients in the first two trials were already taking levetiracetam, which binds the same protein. In those patients, adding brivaracetam did nothing extra, and the label says so.
What was measured
Efficacy of added brivaracetam in the subgroup already taking concomitant levetiracetam
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The label states that in Studies 1 and 2, which evaluated brivaracetam 50 and 100 mg daily, approximately 20% of patients were on concomitant levetiracetam, and that although the numbers of patients were limited, brivaracetam provided no added benefit when it was added to levetiracetam. Study 3, the largest and the only one that produced effect sizes above 25% over placebo, excluded patients on concomitant levetiracetam entirely, though approximately 54% had prior exposure. This is the most direct available test of the premise that a twenty-fold higher affinity at SV2A yields a clinically distinguishable drug: if the higher-affinity ligand cannot displace the lower-affinity one to therapeutic effect at achievable concentrations, the affinity difference does not translate. The label reports the observation and draws no conclusion from it, and no dedicated trial has since been run to settle it.
Source
Brivaracetam United States prescribing information, Clinical Studies 14, Treatment with Levetiracetam (openFDA drug label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Doubling the dose from 100 to 200 mg added nothing
In plain words
In the largest trial, 100 mg a day reduced seizures 25.2% more than placebo and 200 mg a day reduced them 25.7% more. Twice the drug produced half a percentage point of extra benefit.
What was measured
Percent reduction over placebo at 100 mg/day against 200 mg/day, alongside dose-related adverse reaction rates
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Study 3 randomised 760 patients across placebo (n=259), 100 mg/day (n=252) and 200 mg/day (n=249), with percent reduction in 28-day partial-onset seizure frequency over placebo as the primary outcome. The results were 25.2% and 25.7%, both statistically significant and separated by 0.5 percentage points. A flat dose-response at the top of the range is informative in two directions: it argues the target is close to saturated at 100 mg, which is consistent with the levetiracetam add-on finding, and it means the higher dose carries the additional somnolence, fatigue and psychiatric burden without a matching gain. Somnolence and fatigue-related reactions ran at 20% at 50 mg/day, 26% at 100 mg/day and 27% at 200 mg/day against 14% on placebo.
Source
Brivaracetam United States prescribing information, Clinical Studies 14, Table 6 and Warnings and Precautions 5.2 (openFDA drug label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The behavioural problem it was built to solve is on its own label at 13%
In plain words
Brivaracetam is usually reached for when levetiracetam causes irritability or aggression. Psychiatric reactions occurred in about 13% of brivaracetam patients in the trials against 8% on placebo, and the labelled list includes psychosis, irritability, depression, aggression and anxiety.
What was measured
Incidence of psychiatric adverse reactions on brivaracetam at least 50 mg/day against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Warnings and Precautions 5.3 states that brivaracetam causes psychiatric adverse reactions, reported in approximately 13% of patients receiving at least 50 mg/day in the Phase 3 controlled adjunctive trials against 8% on placebo, and names psychotic symptoms, irritability, depression, aggressive behaviour and anxiety. For comparison, the levetiracetam label reports non-psychotic behavioural symptoms in 13% of adults against 6% on placebo and 38% of paediatric patients against 19%. The two numbers are not directly comparable, because the definitions, populations and trial designs differ and no head-to-head trial exists. What can be said is that the drug developed to escape a behavioural problem carries a placebo-controlled behavioural signal of its own, and the label does not claim otherwise.
Source
Brivaracetam United States prescribing information, Warnings and Precautions 5.3; levetiracetam United States prescribing information, Warnings and Precautions 5.1 (openFDA drug label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Dose-dependent somnolence, and unsteadiness in one patient in six
In plain words
A quarter of patients on brivaracetam reported drowsiness or fatigue against 14% on placebo, and 16% reported dizziness or problems with balance and walking against 10%.
What was measured
Incidence of somnolence and fatigue-related reactions by dose, and of dizziness and gait disturbance, against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Warnings and Precautions 5.2 states that brivaracetam causes dose-dependent increases in somnolence and fatigue-related adverse reactions, grouping fatigue, asthenia, malaise, hypersomnia, sedation and lethargy. These occurred in 25% of patients on at least 50 mg/day, specifically 20% at 50 mg/day, 26% at 100 mg/day and 27% at 200 mg/day, against 14% on placebo. Dizziness and disturbance in gait and coordination, grouping dizziness, vertigo, balance disorder, ataxia, nystagmus, gait disturbance and abnormal coordination, occurred in 16% of those on at least 50 mg/day against 10% on placebo. The label notes the risk is greatest early in treatment but can occur at any time, which matters more here than for most drugs because brivaracetam is started at a therapeutic dose with no titration period at all.
Source
Brivaracetam United States prescribing information, Warnings and Precautions 5.2 (openFDA drug label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Schedule V, on the same kind of supratherapeutic euphoria study as lacosamide
In plain words
At recommended doses brivaracetam caused less sedation and euphoria than a benzodiazepine. At four to twenty times the recommended single dose it looked similar on other abuse measures, which is why it is scheduled.
What was measured
Sedative and euphoric effects at therapeutic and supratherapeutic single doses against alprazolam
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In a human abuse potential study, single doses of brivaracetam at therapeutic and supratherapeutic levels were compared with alprazolam 1.5 mg and 3 mg. At the recommended single dose of 50 mg, brivaracetam caused fewer sedative and euphoric effects than alprazolam. At supratherapeutic single doses of 200 mg and 1,000 mg it was similar to alprazolam on other measures of abuse. Brivaracetam is a Schedule V controlled substance in the United States, the same schedule as lacosamide and reached by the same kind of study. Scheduling adds real prescribing friction that has no counterpart in the levetiracetam it is meant to replace, which is not a controlled substance at all.
Source
Brivaracetam United States prescribing information, Drug Abuse and Dependence 9.1 and 9.2 (openFDA drug label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Efficacy has only ever been measured against placebo, in a 23-year refractory population
In plain words
All three registration trials added brivaracetam or a dummy to the treatment of people who had already had epilepsy for about 23 years and had failed one or two other drugs. There is no trial comparing it with any other drug, and none in newly diagnosed patients.
What was measured
That brivaracetam is interchangeable with, or preferable to, levetiracetam or any other anti-seizure drug. Every efficacy number it has is against placebo in refractory add-on use.
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The three fixed-dose randomised double-blind placebo-controlled studies included 1,550 patients whose partial-onset seizures were not adequately controlled on 1 to 2 concomitant anti-seizure drugs, with 72% to 86% taking two or more concomitant drugs with or without vagal nerve stimulation, a median baseline of 9 seizures per 28 days and a mean epilepsy duration of approximately 23 years. All had an 8-week baseline and a 12-week treatment period with no titration. That design supports one claim: brivaracetam does more than nothing when added to failing treatment in long-standing refractory focal epilepsy. It supports no claim about monotherapy, about newly diagnosed epilepsy, or about how brivaracetam compares with any alternative. Its sibling lacosamide, from the same company, did run an active-comparator monotherapy trial; brivaracetam has not.
Source
Brivaracetam United States prescribing information, Clinical Studies 14 (openFDA drug label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
21 documents were read for this substance.
RNAWiki source record
21 of them state the same halfLife, and they agree.
RNAWiki source record
21 of them state the same tMax, and they agree.
RNAWiki source record
21 of them state the same proteinBinding, and they agree.
RNAWiki source record
21 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
U863JGG2IA
RxNorm concept
1739768
Checks this page had to pass
✓ Passed
Identity resolved
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no quarantine open
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Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
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✗ Not passed
Safety mode resolved
No register row and no identity class settled the question.
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Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
23 approved applications cover products containing this substance. The earliest was NDA205837, approved 20160218 to UCB INC.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A levetiracetam successor with roughly twenty-fold higher SV2A affinity, which reduced 28-day seizure frequency by 25.2% over placebo at 100 mg/day in its largest trial but failed to separate from placebo at either dose in its first pivotal study, and whose label records the finding that most directly tests its own premise: added to levetiracetam, it provided no added benefit.
Recorded evidence blocks (10)
Q1
On the Brivaracetam label: indicated for what?
"BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.": indications and usage on Brivaracetam's label. DailyMed label · 3cf2f439-0e97-443e-8e33-25ecef616f6c · 2026-08-20
Q2
50 registered trials of Brivaracetam — at which phases?
Registered studies posting no result
20 of 50
50 registered studies of Brivaracetam: 25 phase3, 13 phase1, 10 phase2, 2 na or unstated, 1 early phase1, 1 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01
77 with a PubMed record
Show the evidence
phase3
25
phase1
13
phase2
10
na or unstated
2
early phase1
1
na
1
7 more recorded rows
completed
39
terminated
5
unknown
2
active not recruiting
1
no longer available
1
not yet recruiting
1
recruiting
1
recorded 2026-09-01 · last checked 2026-09-04
Q3
5 of Brivaracetam's trials stopped: safety, accrual/recruitment?
"An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected."; 5 of 50 registered studies
Show the evidence
Trial
NCT00698581
terminated; "An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected."
NCT00699283
terminated; "An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected"
NCT02088957
terminated; "Termination of study due to low enrollment. There were no safety issues."
NCT03325439
terminated; "Terminated (The study stopped prematurely due to enrolment challenges, the termination was not linked to any safety issues.)"
NCT05029960
terminated; "lack of enrollment"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Brivaracetam used Brivaracetam 25 mg — over how long?
Human studies of Brivaracetam used "Brivaracetam 25 mg". ClinicalTrials.gov · 2026-09-01
12 recorded entries; human; oral, intravenous, tablet; also "Brivaracetam 50 mg", "Brivaracetam 2.5 mg", "Brivaracetam 10 mg"
Show the evidence
human
NCT00357669
Brivaracetam 25 mg
NCT00357669
Brivaracetam 50 mg
NCT00464269
Brivaracetam 2.5 mg
NCT00464269
Brivaracetam 10 mg
NCT01796899
oral; Brivaracetam 10 mg oral tablet
NCT01796899
oral; Brivaracetam 50 mg oral tablet
6 more recorded rows
humanNCT01796899
oral; Brivaracetam 75 mg oral tablet
humanNCT01796899
oral; Brivaracetam 100 mg oral tablet
humanNCT01796899
intravenous; 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)
9 hours; The terminal plasma half-life (t 1/2 ) is approximately 9 hours.
tmaxpharmacokinetics
1 hour; The median T max for tablets taken without food is 1 hour (range 0.25 to 3 hours).
metabolismpharmacokinetics
Elimination Metabolism Brivaracetam is primarily metabolized by hydrolysis of the amide moiety to form the corresponding carboxylic acid metabolite, and secondarily by hydroxylation on the propyl side chain to form the hydroxy metabolite.
recorded 2026-08-20 · last checked 2026-09-04
Q6
Which 10 trials of Brivaracetam posted no result?
Posted no result
10 of 10 completed trials
Registrations
NCT00401648, NCT00175929, NCT00426673, NCT00357669, NCT00736931 and NCT01710670, and 4 more
Completion dates
oldest 2003-06; newest 2023-08-29
Show the evidence
Trial
NCT00401648
2003-06
NCT00175929
2006-03
NCT00426673
2006-06
NCT00357669
2007-10
NCT00736931
2008-10
NCT01710670
2012-11
4 further recorded trials
NCT01796899
2013-03
NCT02602860
2017-09
NCT03685630
2021-03-27
NCT03517423
2023-08-29
Q7
At the median, Brivaracetam's trials enrolled 62 people — anything larger?
Median enrolment
62
Largest enrolment
853
Registered trials counted
49
Q8
What do 968 spontaneous reports say about Brivaracetam — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Brivaracetam appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 968 reaction mentions were counted: seizure 373; dizziness 76; fatigue 74; aggression 72. FAERS via Open Targets · CHEMBL607400 · 2026-06-24
Show the evidence
seizure
373
dizziness
76
fatigue
74
aggression
72
generalised tonic-clonic seizure
72
depression
71
4 more recorded rows
somnolence
64
irritability
62
suicidal ideation
62
anxiety
42
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Brivaracetam's label not list?
An additional hydroxy acid metabolite is created by hydrolysis of the amide moiety on the hydroxy metabolite or hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9).
pharmacokinetics
Drug Interaction Studies In Vitro Assessment of Drug Interactions Drug-Metabolizing Enzyme Inhibition Brivaracetam did not inhibit CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, or 3A4.
pharmacokinetics
Drug-Metabolizing Enzyme Induction Brivaracetam at concentrations up to 10 μM caused little or no change of mRNA expression of CYP1A2, 2B6, 2C9, 2C19, 3A4, and epoxide hydrolase.
pharmacokinetics
Transporters Brivaracetam was not a substrate of P-gp, MRP1, or MRP2.
pharmacokinetics
Brivaracetam did not inhibit or weakly inhibit BCRP, BSEP, MATE1, MATE2/K, MRP2, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, or P-gp, suggesting that brivaracetam is unlikely to inhibit these transporters in vivo .
pharmacokinetics
Pregabalin No data None Topiramate None None Valproic acid None None Zonisamide No data None Drug Interaction Studies with Other Drugs Effect of Other Drugs on BRIVIACT Co-administration with CYP inhibitors or transporter inhibitors is unlikely to significantly affect brivaracetam exposure.
2 more recorded rows
Interaction statementclinical_pharmacology
An additional hydroxy acid metabolite is created by hydrolysis of the amide moiety on the hydroxy metabolite or hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9).
Interaction statementclinical_pharmacology
Drug Interaction Studies In Vitro Assessment of Drug Interactions Drug-Metabolizing Enzyme Inhibition Brivaracetam did not inhibit CYP1A2, 2A6, 2B6, 2C8, 2C9, 2D6, or 3A4.
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 6 source rows
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