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VIGAB-STAT: VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT04772547
Collaborator
Yale University (Other), Thomas Jefferson University (Other)
12
Enrollment
1
Location
1
Arm
15.3
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Vigabatrin Only Product
 Phase 2

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
pilot feasibility trial of pharmacokinetics of drug absorptionpilot feasibility trial of pharmacokinetics of drug absorption
Masking:
None (Open Label)
Masking Description:
Participants are unconscious, thus, inherently blinded to the intervention. All the endpoints are objective and will be assessed by a blinded investigator to the timing of vigabatrin administration.
Primary Purpose:
Treatment
Official Title:
VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
Actual Study Start Date :
Sep 22, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Open label

4500 mg of vigabatrin administered enterally

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vigabatrin levels [up to day 7]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Gainesville Florida United States 32610

    Sponsors and Collaborators

    • University of Florida
    • Yale University
    • Thomas Jefferson University

    Investigators

    • Principal Investigator: Carolina B Maciel, MD, MSCR, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT04772547
    Other Study ID Numbers:
    • VIGAB-STAT IIa
    • IRB202003076
    • OCR40379
    First Posted:
    Feb 26, 2021
    Last Update Posted:
    Dec 22, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Florida
    post-anoxic status epilepticus, cardiac arrest, nonconvulsive status epilepticus, coma, vigabatrin
    Additional relevant MeSH terms:
    Status Epilepticus
    Vigabatrin

    Study Results

    No Results Posted as of Dec 22, 2021