VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa (VIGAB-STAT)

February 12, 2024 updated by: University of Florida
This is a pilot trial of a single loading dose of vigabatrin in post-anoxic status epilepticus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vigabatrin levels
Time Frame: 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.
up to day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Yale University
American Heart Association
Thomas Jefferson University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIGAB-STAT IIa
  • IRB202003076 (Other Identifier: UF IRB-01)
  • OCR40379 (Other Identifier: UF OnCore)
  • PRO00031111 (Other Identifier: UFIRST)
  • 20IPA35380013 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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