NCT04772547

VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Status Epilepticus, Electrographic
• Coma

Interventions

Type	Name	Description
DRUG	Vigabatrin Only Product	enteral medication administration, serial blood draws, and outcome assessment

Timeline

• Start date: 2021-09-22
• Primary completion: 2023-06-07
• Completion: 2024-01-23
• First posted: 2021-02-26
• Last updated: 2024-07-23
• Results posted: 2024-07-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study