VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa (VIGAB-STAT)

University of Florida

Status and phase: Completed; Phase 2

Conditions: Coma; Status Epilepticus, Electrographic

Treatments: Drug: Vigabatrin Only Product

Study type: Interventional

Funder types: Other

Identifiers

NCT04772547

IRB202003076 (Other Identifier)

VIGAB-STAT IIa

20IPA35380013 (Other Grant/Funding Number)

PRO00031111 (Other Identifier)

OCR40379 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Open label

Experimental group

Description:

4500 mg of vigabatrin administered enterally

Treatment:

Drug: Vigabatrin Only Product