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Gamma-Aminobutyric Acid (GABA) Transaminase Inhibitor

Vigabatrin for Post-anoxic Seizures (VIGAB-STAT Trial)

Phase 2
Waitlist Available
Led By Carolina B Maciel, MD, MSCR
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-traumatic cardiac arrest in whom the decision to treat unequivocal electrographic status epilepticus has been made
Requiring anesthetic infusion for any reason
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 7
Awards & highlights

VIGAB-STAT Trial Summary

This trial is testing a new treatment for seizures that occur after a person has been without oxygen for a period of time.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Vigabatrin can cause side effects like sleepiness, headache, joint pain, vision changes, and dizziness. It may also lead to more serious issues such as anemia or nerve problems affecting the eyes.

VIGAB-STAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.
Select...
You need anesthesia for any reason.
Select...
You need to have a good artery that can be used to take blood samples often.
Select...
You have a tube inserted into your stomach within 48 hours after having a certain type of prolonged seizure.

VIGAB-STAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vigabatrin levels

VIGAB-STAT Trial Design

1Treatment groups
Experimental Treatment
Group I: Open labelExperimental Treatment1 Intervention
4500 mg of vigabatrin administered enterally
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vigabatrin Only Product
2021
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityOTHER
442 Previous Clinical Trials
145,434 Total Patients Enrolled
1 Trials studying Status Epilepticus
15 Patients Enrolled for Status Epilepticus
Yale UniversityOTHER
1,837 Previous Clinical Trials
2,728,407 Total Patients Enrolled
2 Trials studying Status Epilepticus
70 Patients Enrolled for Status Epilepticus
University of FloridaLead Sponsor
1,333 Previous Clinical Trials
714,585 Total Patients Enrolled
1 Trials studying Status Epilepticus

Media Library

Vigabatrin (Gamma-Aminobutyric Acid (GABA) Transaminase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04772547 — Phase 2
Status Epilepticus Research Study Groups: Open label
Status Epilepticus Clinical Trial 2023: Vigabatrin Highlights & Side Effects. Trial Name: NCT04772547 — Phase 2
Vigabatrin (Gamma-Aminobutyric Acid (GABA) Transaminase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04772547 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to join this experimentation?

"This medical research is searching for 22 individuals suffering from a coma, aged between 18 and 80. Criteria to be eligible are non-traumatic cardiac arrest (regardless of etiology or location), the presence of electrographic status epilepticus as defined by the American Clinical Neurophysiology Society (generalized spike/sharp-wave discharges ≥ 3Hz or any evolving pattern reaching > 4Hz, lasting ≥ 10 minutes, or comprising > 50% of any hour of recording) and reliable arterial access for frequent blood sampling."

Answered by AI

Has the Food and Drug Administration certified Vigabatrin as a sole therapeutic agent?

"We have given Vigabatrin Only Product a security rating of 2 based on the data currently available from Phase 2 trials, which confirms its safety but does not demonstrate efficacy."

Answered by AI

Could you please expound on the past experiments conducted using Vigabatrin Only Product?

"Presently, 7 trials relating to Vigabatrin Only Product are in progress. Two of these investigations have progressed to Phase 3. 44 distinct sites across Birmingham, Alabama are conducting the research into this medicine's efficacy and safety."

Answered by AI

Are persons of age 18 and above welcome to join this trial?

"According to the criteria listed on this trial, patients aged 18 - 80 are eligible for enrollment. For those below and above these respective age groups, there are 11 studies tailored to minors and 14 specifically designed for elderly individuals."

Answered by AI

To what extent has the clinical trial been tested on participants?

"Affirmative. According to records on clinicaltrials.gov, this research endeavour is actively recruiting participants since it was first declared on September 22nd 2021 and last updated on the 19th of September 2022. The trial requires a total of 22 individuals at one medical centre."

Answered by AI

Is this trial currently recruiting participants?

"Affirmative. Data stored on clinicaltrials.gov affirms that this medical research, which was initially posted September 22nd 2021, is actively seeking applicants. Approximately 22 volunteers must be sourced from one location."

Answered by AI
~2 spots leftby Mar 2025