What side effects are associated with this type of intervention?

Common treatments for Status Epilepticus that increase GABA levels, such as Vigabatrin, benzodiazepines, barbiturates, and valproate, have various side effects. Vigabatrin can cause visual field defects, drowsiness, dizziness, and fatigue. Benzodiazepines may lead to sedation, respiratory depression, and hypotension. Barbiturates can also cause sedation, respiratory depression, and hypotension. Valproate is associated with hepatotoxicity, weight gain, and gastrointestinal disturbances.

What prior FDA approvals exist?

FDA-approved treatments for Status Epilepticus primarily include benzodiazepines such as lorazepam, diazepam, and midazolam, which enhance GABAergic activity by increasing the frequency of chloride channel opening. Other treatments include barbiturates like phenobarbital, which prolong the duration of chloride channel opening, and antiepileptic drugs like valproate, which increases GABA levels by inhibiting GABA transaminase, similar to Vigabatrin. While Vigabatrin itself is not FDA-approved for Status Epilepticus, its mechanism of increasing GABA levels is shared with valproate, an established treatment option.

What other types of research exist?

Promising novel alternatives to Vigabatrin for Status Epilepticus patients include Brivaracetam, which binds to synaptic vesicle protein 2A (SV2A) to modulate neurotransmitter release, and Perampanel, an AMPA receptor antagonist that reduces excitatory neurotransmission. Both have shown efficacy in recent studies and offer different mechanisms of action compared to Vigabatrin.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Feasibility Outcome - Enrollment and Drug Delivery

Primary Feasibility Outcome - Participants With Visual Screening for Taurine Levels

Primary Feasibility Outcome - Visual Screening (Goldmann Perimetry)

+1 more

Secondary study objectives

PASE Onset Detection

Secondary Pharmacologic Outcome: Elimination

Ultra-early Vigabatrin Administration

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Status Epilepticus (SE) primarily aim to enhance GABAergic activity to quickly terminate seizures and prevent neuronal damage. Benzodiazepines and barbiturates enhance the effect of GABA at the GABA-A receptor, increasing neuronal inhibition. Phenytoin and fosphenytoin stabilize neuronal membranes by inhibiting voltage-gated sodium channels. Vigabatrin, an investigational treatment, irreversibly inhibits GABA transaminase, increasing GABA levels and restoring the inhibitory-excitatory balance in the brain. This mechanism is crucial for SE patients to effectively stop prolonged or repeated seizures.