VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

VIGAB-STAT IIa

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

2021-09-22

2023-12-31

2023-12-31

Completed

Early phase I

6

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'pilot feasibility trial of pharmacokinetics of drug absorption', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants are unconscious, thus, inherently blinded to the intervention. All the endpoints are objective and will be assessed by a blinded investigator to the timing of vigabatrin administration.'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

2024-02-14