VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

Coma Clinical Trial

— VIGAB-STAT  

Official title:

VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772547
• Other study ID #: VIGAB-STAT IIa
• Secondary ID: IRB202003076OCR4
• Status: Completed
• Phase: Phase 2
• Start date: September 22, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coma
• Status Epilepticus
• Status Epilepticus, Electrographic

Intervention

Drug:
• Vigabatrin Only Product
enteral medication administration, serial blood draws, and outcome assessment

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
University of Florida	American Heart Association, Thomas Jefferson University, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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