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Vigabatrin

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Vigabatrin does in the body

Vigabatrin tablets are indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments;

From the FDA-approved label: The precise mechanism of vigabatrin’s anti-seizure effect is unknown, but it is believed to be the result of its action as an irreversible inhibitor of γ -aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA. This action results in increased levels of GABA in the central nervous system. No direct correlation between plasma concentration and efficacy has been established. The duration of drug effect is presumed to be dependent on the rate of enzyme re-synthesis rather than on the rate of elimination of the drug from the systemic circulation.

Why people take it. Vigabatrin tablets are indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments;

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · GR120KRT6K · read 2026-08-29

  • Its recorded molecular formula is C6H11NO2, weighing 129.16.

    US prescribing information · 0afdc84c-f8ec-330a-31c9-fac4ed256931 · read 2026-08-30

Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 172 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.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

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.

What happened in peopleRead 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.

A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).

The study did not show it

Who was studied
NCT03347526
How many people
394
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Cessation of spasms

The study did not show it

Who was studied
NCT04302116
How many people
250
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Abstinence

The study did not show it

Who was studied
NCT01281202
How many people
207
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.

The study did not show it

Who was studied
NCT00611130
How many people
186
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Number of seizures

The study did not show it

Who was studied
NCT02205931
How many people
160
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed).

The study did not show it

Who was studied
NCT00527683
How many people
100
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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 is missing or unclearRead 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.

  • Vigabatrin tablets are indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; Vigabatrin tablets are not indicated as a first line agent ( 1.1 ) Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of…

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: “Duration of therapy for infantile spasms was evaluated in a post hoc analysis of a Canadian Pediatric Epilepsy Network (CPEN) study of developmental outcomes in infantile spasms patients.”

    US prescribing information · 0afdc84c-f8ec-330a-31c9-fac4ed256931 · read 2026-08-30

  • On older people, the label states: “Clinical studies of vigabatrin did not include sufficient numbers of patients aged 65 and over to determine whether they responded differently from younger patients.”

    US prescribing information · 0afdc84c-f8ec-330a-31c9-fac4ed256931 · 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 AEDs, including vigabatrin, during pregnancy.”

    US prescribing information · 0afdc84c-f8ec-330a-31c9-fac4ed256931 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Vigabatrin is excreted in human milk.”

    US prescribing information · 0afdc84c-f8ec-330a-31c9-fac4ed256931 · read 2026-08-30

  • On people with reduced kidney function, the label states: “Dose adjustment, including initiating treatment with a lower dose, is necessary in pediatric patients 2 years of age and older and adults with mild (creatinine clearance >50 to 80 mL/min), moderate (creatinine clearance >30 to 50 mL/min) and severe (creatinine clearance >10 to 30 mL/min) renal impairment [ see Dosage and Administration ( 2.4 ) and Clinical Pharmacology ( 12.3 ) ].”

    US prescribing information · 0afdc84c-f8ec-330a-31c9-fac4ed256931 · read 2026-08-30

Where the result stopped carrying

  • 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 takeRead 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 takeRead 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

Prescription only

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

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

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S5.

No source is stored against this line.

What is in the pack

Sold as for solution, solution, tablet, powder, for solution, given by the oral route.

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 and what that means for what is in the pack.

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 takeNothing found in the sources checked

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.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

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 unclearRead 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

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 37 products list this as an active ingredient in the United States drug directory. 37 of them contain it and nothing else.

    FDA National Drug Code directory · 17337-0556 · read 2026-08-29

  • They are sold as for solution, powder, powder, for solution, solution, tablet and tablet, film coated, taken oral.

    FDA National Drug Code directory · 17337-0556 · read 2026-08-29

  • The regulator's established pharmacologic class for it is anti-epileptic agent [epc].

    FDA National Drug Code directory · 17337-0556 · read 2026-08-29

  • 25 published labels name it as an active ingredient. 25 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 0afdc84c-f8ec-330a-31c9-fac4ed256931 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 0afdc84c-f8ec-330a-31c9-fac4ed256931 · read 2026-08-29

  • Vigabatrin is oral at 3 DOSAGE FORMS AND STRENGTHS Tablet: 500 mg: White to off white color, oval shape, film-coated tablets debossed with 'l l' on one side and 'break line' on other side., recorded as fda label in effect 2020-03-17 in the United States.

    US prescribing information · 0afdc84c-f8ec-330a-31c9-fac4ed256931 · read 2026-08-30

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 takeRead 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.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Vigabatrin 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 unclearRead 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 Vigabatrin 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 peopleRead 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.

How many documents were read

  • 25 documents were read for this substance.

    RNAWiki source record

  • 25 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
GR120KRT6K
RxNorm concept
199521

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Quoted from a stored source.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S5.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead 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.

  1. Withdrawn in United States, 2023, for "Defective Container: powder may leak out of the pouch" (openFDA drug enforcement Class I recall)

What the approval register records

  • 30 approved applications cover products containing this substance. The earliest was NDA022006, approved 20090821 to LUNDBECK PHARMS LLC.

    Drugs@FDA application register · NDA022006 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA022006 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20070818.

    FDA National Drug Code directory · 17337-0556 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 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.
  • The path through the body — 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.
  • Claims that go past the evidence — 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.

Recorded evidence blocks (10)

On the Vigabatrin label: indicated for what?


"Vigabatrin tablets are indicated for the treatment of: • Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; Vigabatrin tablets are not indicated as a first line agent ( 1.1 ) • Infantile Spasms - monotherapy…": indications and usage on Vigabatrin's label. DailyMed label · 93ba3894-fd97-4432-9f2d-e7050371e91f · 2026-08-12

23 registered trials of Vigabatrin — at which phases?


Registered studies posting no result
14 of 23

23 registered studies of Vigabatrin: 9 phase2, 6 phase3, 4 phase1, 4 phase4, 2 na, 1 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

203 with a PubMed record

Show the evidence
  • phase2
    9
  • phase3
    6
  • phase1
    4
  • phase4
    4
  • na
    2
  • na or unstated
    1
6 more recorded rows
  • completed
    11
  • terminated
    4
  • withdrawn
    4
  • unknown
    2
  • recruiting
    1
  • suspended
    1

recorded 2026-09-01 · last checked 2026-09-04

7 of Vigabatrin's trials stopped: futility/efficacy, accrual/recruitment, funding/business?


futility/efficacy (2), accrual/recruitment (3) and funding/business (2): Vigabatrin's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Funding ran out"; 7 of 23 registered studies

Show the evidence

Trial

  • NCT00373581
    terminated; "Funding ran out"
  • NCT01266291
    terminated; "Was not possible to enroll sufficient number of subjects to draw any worthwhile conclusions from the study."
  • NCT01335867
    terminated; "interim analysis of efficacy completed and termination recommended"
  • NCT02299115
    withdrawn; "Most centres are now using oral steroids as 1st line treatment so question of efficacy is no longer of high interest."
  • NCT03347526
    suspended; "Study on enrollment hold as a precaution per the pharmaceutical company."
  • NCT03421496
    terminated; "The study was terminated due to slow enrollment and failure to identify adequate patients that met entry criteria."
  • 1 further recorded trial NCT05128344
    withdrawn; "Strategic decision"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Vigabatrin used Vigabatrin 500 MG — over how long?


studies of Vigabatrin used the recorded amount. ClinicalTrials.gov · 2026-09-01

2 recorded entries; human; also "Vigabatrin 500 MG", "Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin"

Show the evidence

human

  • NCT03003143
    Vigabatrin 500 MG
  • NCT03347526
    Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin

recorded 2026-09-01 · last checked 2026-09-04

Vigabatrin's half-life is 5.7 hours — which schedules were studied?


5.7 hours, the half-life Vigabatrin's label states: "The terminal half-life of vigabatrin is about 5.7 hours for infants (5 months to 2 years of age), 6.8 hours for children (3 to 9 years of age), 9.5 hours for children and adolescents (10 to 16 years of age), and 10.5 hours for adults." DailyMed label · 93ba3894-fd97-4432-9f2d-e7050371e91f · 2026-08-12

tmax 1 hour.

Show the evidence
  • half life pharmacokinetics
    5.7 hours; The terminal half-life of vigabatrin is about 5.7 hours for infants (5 months to 2 years of age), 6.8 hours for children (3 to 9 years of age), 9.5 hours for children and adolescents (10 to 16 years of age), and 10.5 hours for adults.
  • tmax pharmacokinetics
    1 hour; The time to maximum concentration (T max ) is approximately 1 hour for children and adolescents (3 years to 16 years of age) and adults, and approximately 2.5 hours for infants (5 months to 2 years of age).
  • metabolism pharmacokinetics
    Metabolism and Elimination Vigabatrin is not significantly metabolized; it is eliminated primarily through renal excretion.

recorded 2026-08-12 · last checked 2026-09-04

Which 4 trials of Vigabatrin posted no result?


Posted no result
4 of 4 completed trials
Registrations
NCT00527683, NCT00506935, NCT00626834 and NCT04468282
Completion dates
oldest 2007-11; newest 2017-08-08
Show the evidence

Trial

  • NCT00527683
    2007-11
  • NCT00506935
    2008-06
  • NCT00626834
    2010-10
  • NCT04468282
    2017-08-08

At the median, Vigabatrin's trials enrolled 24 people — anything larger?


Median enrolment
24
Largest enrolment
9423
Registered trials counted
23

What do 2363 spontaneous reports say about Vigabatrin — 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.

Vigabatrin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2363 reaction mentions were counted: seizure 963; drug withdrawal convulsions 255; pneumonia 234; somnolence 207. FAERS via Open Targets · CHEMBL89598 · 2026-06-24

Show the evidence
  • seizure
    963
  • drug withdrawal convulsions
    255
  • pneumonia
    234
  • somnolence
    207
  • convulsion
    146
  • infantile spasms
    130
4 more recorded rows
  • irritability
    111
  • status epilepticus
    108
  • visual field defect
    105
  • visual impairment
    104

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Vigabatrin's label not list?


convulsion, drug withdrawal convulsions and infantile spasms and 7 more reported for Vigabatrin, absent from its label. FAERS via Open Targets · CHEMBL89598 · 2026-06-24

2 label terms; 10 reported and unlisted; 93ba3894-fd97-4432-9f2d-e7050371e91f

Show the evidence
  • convulsion
    count not stated
  • drug withdrawal convulsions
    count not stated
  • infantile spasms
    count not stated
  • irritability
    count not stated
  • pneumonia
    count not stated
  • seizure
    count not stated
4 more recorded rows
  • somnolence
    count not stated
  • status epilepticus
    count not stated
  • visual field defect
    count not stated
  • visual impairment
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Vigabatrin and CYTOCHROME P450, CYP2C9 and CYP3A: shared by which compounds?


CYTOCHROME P450, CYP2C9 and CYP3A appear in Vigabatrin's recorded interaction sentences, 6 in all. DailyMed label · 93ba3894-fd97-4432-9f2d-e7050371e91f · 2026-08-12

CYP2C9, CYP3A; 2 shared nodes; pharmacokinetics, clinical_pharmacology

Show the evidence

Interaction statement

  • pharmacokinetics
    Vigabatrin induces CYP2C9, but does not induce other hepatic cytochrome P450 enzyme systems.
  • pharmacokinetics
    In vitro drug metabolism studies indicate that decreased phenytoin concentrations upon addition of vigabatrin therapy are likely to be the result of induction of cytochrome P450 2C enzymes in some patients.
  • pharmacokinetics
    Oral Contraceptives In a double-blind, placebo-controlled study using a combination oral contraceptive containing 30 mcg ethinyl estradiol and 150 mcg levonorgestrel, vigabatrin (3 g/day) did not interfere significantly with the cytochrome P450 isoenzyme (CYP3A)-mediated metabolism of the contraceptive tested.
  • clinical_pharmacology
    Vigabatrin induces CYP2C9, but does not induce other hepatic cytochrome P450 enzyme systems.
  • clinical_pharmacology
    In vitro drug metabolism studies indicate that decreased phenytoin concentrations upon addition of vigabatrin therapy are likely to be the result of induction of cytochrome P450 2C enzymes in some patients.
  • clinical_pharmacology
    Oral Contraceptives In a double-blind, placebo-controlled study using a combination oral contraceptive containing 30 mcg ethinyl estradiol and 150 mcg levonorgestrel, vigabatrin (3 g/day) did not interfere significantly with the cytochrome P450 isoenzyme (CYP3A)-mediated metabolism of the contraceptive tested.
  • CYP2C9
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Tinidazole, Naldemedine
  • CYP3A
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib

recorded 2026-08-12 · last checked 2026-09-04

Where it is registered

Where it’s registered

Withdrawn in United States, 2023, for "Defective Container: powder may leak out of the pouch" (openFDA drug enforcement Class I recall)

Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL89598
PubChem CID
10219440
CAS number
74046-07-4
RxCUI
199521
InChIKey
PJDFLNIOAUIZSL-UHFFFAOYSA-N
Also called
5-hexenoic acid, 4-amino-, Gamma vinyl gaba, Vigabatrina, Vigabatrine, Vigafyde, Vinyl gamma-aminobutyric acid, cpp-109 vigabatrin, gvg, vgb, VIGABATRIN [USP-RS], Vigabatrin [EP MONOGRAPH], Vigabatrin [INN]
Development code
CPP-109, MDL 71,754, MDL-71754, RMI-71754
Trade name
Kigabeq, Sabril, Vigadrone, Vigpoder
Salt form
Vigabatrin For Oral Solution, Sabril / Vigadrone / Vigafyde / Vigpoder / Vigabatrin For Oral Solution
Sources (7)

Sources

1 more source

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 · openFDA enforcement — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • 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: 7 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.