Phase 2 N=6 Treatment

VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

Status Epilepticus, Electrographic · Coma

Bottom Line

View on ClinicalTrials.gov: NCT04772547 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Primary Pharmacologic Outcome - Absorption — 6; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Vigabatrin Only Product (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Pharmacologic Outcome - Absorption	6; 0	—
PRIMARY Primary Feasibility Outcome - Enrollment and Drug Delivery	6; 0	—
PRIMARY Primary Feasibility Outcome - Visual Screening (Goldmann Perimetry)	—	—
PRIMARY Primary Feasibility Outcome - Participants With Visual Screening for Taurine Levels	6; 4; 1	—
SECONDARY Ultra-early Vigabatrin Administration	1; 3; 2	—
SECONDARY Secondary Pharmacologic Outcome: Elimination	2; 2; 2; 0	—
SECONDARY PASE Onset Detection	8	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04772547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.