Vigabatrin for Post-anoxic Seizures

(VIGAB-STAT Trial)

Overseen By Ralisa Pop, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Disqualifiers: Generalized epilepsy, Recent GI surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

6 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a single large dose of vigabatrin to help control seizures in unconscious patients who have had a cardiac arrest. These patients are experiencing seizures due to a lack of oxygen to the brain. Vigabatrin works by boosting a natural brain chemical that helps to calm the brain and stop seizures. Vigabatrin is an antiepileptic drug designed to increase levels of a calming brain chemical to reduce seizure activity.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Vigabatrin for treating post-anoxic seizures?

Vigabatrin has been shown to increase brain levels of GABA, a chemical that helps calm nerve activity, and has been effective in reducing seizures in patients with chronic epilepsy. In animal studies, Vigabatrin reduced seizure severity and mortality when administered after hypoxia (low oxygen levels), suggesting it may help in similar conditions like post-anoxic seizures. ^{1 2 3 4 5}

Is Vigabatrin generally safe for use in humans?

Vigabatrin has been used safely in many patients for treating seizures, but it can cause side effects like drowsiness, sleep disturbances, and in rare cases, psychosis or new seizures. There are also concerns about its effects on vision and brain function, so safety monitoring is important. ^{6 7 8 9 10}

How does the drug Vigabatrin differ from other treatments for post-anoxic seizures?

Vigabatrin is unique because it increases levels of GABA (a calming brain chemical) by blocking its breakdown, which may help stop seizures after a lack of oxygen to the brain. Unlike other treatments, it specifically targets the GABA pathway and is being explored as a new option for post-anoxic seizures, a condition with no proven therapies. ^{1 3 8 11 12}

Research Team

Carolina B Maciel, MD, MSCR

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for adults over 18 who've had a non-traumatic cardiac arrest and are in a coma with continuous epileptic seizures, requiring anesthesia. They must have reliable arterial access for blood tests and a way to receive medication through the digestive system within 48 hours of seizure onset.

Inclusion Criteria

Age ≥ 18 years

You had a sudden stop in your heart that wasn't caused by an injury, and your doctor has decided that you need treatment for continuous abnormal brain activity.

You need anesthesia for any reason.

Exclusion Criteria

History of gastrointestinal surgery within the last 21 days

Pregnancy

You have had seizures all over your body before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

48 hours

Treatment

A single loading dose of vigabatrin is administered within 48 hours of post-anoxic status epilepticus onset

48 hours

In-hospital administration

Monitoring

Serial blood tests are obtained to monitor vigabatrin levels, taurine levels, and other biomarkers

7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including visual field perimetry at 6 months

6 months

Treatment Details

Interventions

• Vigabatrin

Trial Overview The study is testing the effects of a single dose of vigabatrin, which is given to patients experiencing persistent epileptic seizures after cardiac arrest. The goal is to see how well it works when standard treatments aren't enough.

Participant Groups

Group I: Open label Experimental Treatment 1 Intervention

4500 mg of vigabatrin administered enterally

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Thomas Jefferson University

Collaborator

Trials

475

Recruited

189,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Early vigabatrin augmenting GABA-ergic pathways in post-anoxic status epilepticus (VIGAB-STAT) phase IIa clinical trial study protocol. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Hypoxia-induced changes of seizure susceptibility in immature rats are modified by vigabatrin. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Vigabatrin: rational treatment for chronic epilepsy. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of vigabatrin as an add-on drug in the management of severe epilepsy. [2019]

5. Norway pubmed.ncbi.nlm.nih.gov

[Vigabatrin--a new antiepileptic agent]. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Multicentre clinical evaluation of vigabatrin (Sabril) in mild to moderate partial epilepsies. French Neurologists Sabril Study Group. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Vigabatrin: a novel therapy for seizure disorders. [2017]

8. Spain pubmed.ncbi.nlm.nih.gov

[Acute encephalopathy and myoclonic status induced by vigabatrin monotherapy] . [2013]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical profile of vigabatrin as monotherapy for treatment of infantile spasms. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Acute encephalopathy associated with vigabatrin in a six-month-old girl. [2019]

11. New Zealand pubmed.ncbi.nlm.nih.gov

A risk-benefit assessment of vigabatrin in the treatment of neurological disorders. [2018]

12. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of vigabatrin on central nervous system oxygen toxicity in rats. [2019]