Skip to main content
OpenTrials
Completed

NCT Number: NCT04772547

VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Status Epilepticus, Electrographic Cardiovascular Diseases Coma Consciousness Disorders Heart Arrest Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Status Epilepticus Unconsciousness

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vigabatrin Only Product

Drug

enteral medication administration, serial blood draws, and outcome assessment

Other names: sabril, vigabatrone

Primary outcomes

  1. Primary Pharmacologic Outcome - Absorption

    Time frame: 3h

    By analyzing serial vigabatrin levels including baseline, we characterized vigabatrin absorption; the target was to achieve a detectable vigabatrin level in the serum of ≥ 80% of enrolled subjects by 3 hours post-load.

  2. Primary Feasibility Outcome - Enrollment and Drug Delivery

    Time frame: 48 hours

    We looked at the ability to deliver vigabatrin within 48 hours of PASE onset in ≥ 80% of enrolled subjects. Vigabatrin dose was adjusted according to renal functioning (CrCl>50 ml/min: 4500 mg, CrCl 30-50 ml/min: 2250 mg, CrCl<30 ml/min: 1125 mg)

  3. Primary Feasibility Outcome - Visual Screening (Goldmann Perimetry)

    Time frame: 6 months

    We planned to obtain Goldmann perimetry testing in the subjects who could cooperate at the 6 months follow-up. Our goal was to have reliable visual field perimetry in ≥ 80% of survivors who regained consciousness following index hospitalization.

  4. Primary Feasibility Outcome - Participants With Visual Screening for Taurine Levels

    Time frame: 0h, 72h and 168h following vigabatrin administration

    We obtained serial taurine levels during ICU stay at time 0h, 72h and 168h following vigabatrin administration. Our goal was to achieve a 90% completion rate for taurine levels.

Secondary outcomes

  1. Ultra-early Vigabatrin Administration

    Time frame: 0h to 48h after vigabatrin admnistration

    We tracked the proportion of enrolled subjects who received a vigabatrin load within 12 and 24 hours of PASE onset to explore the possibility of ultra-early administration of vigabatrin in subsequent phases.

  2. Secondary Pharmacologic Outcome: Elimination

    Time frame: 72h and 7 days following vigabatrin administration

    By analyzing serial VGB levels, we characterized drug elimination. We anticipated subjects with normal renal function would have undetectable vigabatrin levels by 72 hours, and those with creatinine clearance less than 30 mL/min would have detectable VGB levels at 72 hours. We anticipated undetectable vigabatrin levels in all subjects by 7 days regardless of their renal function.

  3. PASE Onset Detection

    Time frame: Determined at the time of connection to EEG monitoring

    We tracked the proportion of subjects in whom PASE was present upon connection to EEG (onset misses) to explore alternatives to allow prompt EEG monitoring following the return of spontaneous circulation (ROSC).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • American Heart Association
  • Thomas Jefferson University
  • Yale University

Registry information

Acronym: VIGAB-STAT

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 26, 2021
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.