Phase 2
Completed N=6
VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
Status Epilepticus, Electrographic · coma
Source: ClinicalTrials.gov NCT04772547 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Primary Pharmacologic Outcome - Absorption — 6; 0 Participants
Summary
This is a pilot trial of a single loading dose of vigabatrin in post-anoxic status epilepticus.
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 | — |
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
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. Informational only — not medical advice.