VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

Study Overview
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Brief Summary
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This is a pilot trial of a single loading dose of vigabatrin in post-anoxic status epilepticus.

Detailed Description
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This pilot trial aims to demonstrate the feasibility of enteral administration of a single load of vigabatrin within targeted 48 hours of post-anoxic status epilepticus onset in unconscious survivors of cardiac arrest undergoing targeted temperature management. The load of VGB is in addition to the load of a commonly used intravenous second-line therapy given at the discretion of the treating neurologist. Serial blood tests will be obtained, including vigabatrin levels, taurine levels, neuron specific enolase, light chain neurofilament, and glial fibrillary acidic protein. In survivors that regain consciousness and survive to follow up, 6 months visual field perimetry will be obtained.

Official Title
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VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

Conditions
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Status Epilepticus, Electrographic, Coma

Intervention / Treatment
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* Drug: Vigabatrin Only Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years non-traumatic cardiac arrest (regardless of non-perfusing rhythm, etiology, or location of arrest) in whom the decision to treat unequivocal electrographic status epilepticus (as defined by the American Clinical Neurophysiology Society: having generalized spike/sharp-wave discharges ≥ 3Hz or any evolving pattern reaching > 4Hz, lasting ≥ 10 minutes, or comprising > 50% of any hour of recording) has been made requiring anesthetic infusion for any reason have reliable arterial access for frequent blood sampling established enteral access within 48h of post-anoxic status epilepticus onset. Exclusion Criteria: prior history of generalized epilepsy history of gastrointestinal surgery within the last 21 days pregnancy status epilepticus onset preceding initiation of electroencephalography monitoring

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: pilot feasibility trial of pharmacokinetics of drug absorption
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label<br>4500 mg of vigabatrin administered enterally | Drug: Vigabatrin Only Product<br>* enteral medication administration, serial blood draws, and outcome assessment<br>* Other names: sabril, vigabatrone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vigabatrin levels | Blood levels of vigabatrin using high-performance liquid chromatography. Detectable levels of vigabatrin in 80% of subjects by 3 hours and 100% of subjects by 12 hours will be considered the threshold for adequate absorption. | up to day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-anoxic status epilepticus, cardiac arrest, nonconvulsive status epilepticus, coma, vigabatrin