Status:
COMPLETED
VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Yale University
Thomas Jefferson University
Conditions:
Status Epilepticus, Electrographic
Coma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- prior history of generalized epilepsy
- history of gastrointestinal surgery within the last 21 days
- pregnancy
- status epilepticus onset preceding initiation of electroencephalography monitoring
Key Trial Info
Start Date :
September 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04772547
Start Date
September 22 2021
End Date
January 23 2024
Last Update
July 23 2024
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610