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

Primary Purpose

Status Epilepticus, Electrographic, Coma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vigabatrin Only Product
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Status Epilepticus, Electrographic focused on measuring post-anoxic status epilepticus, cardiac arrest, nonconvulsive status epilepticus, coma, vigabatrin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open label

Arm Description

4500 mg of vigabatrin administered enterally

Outcomes

Primary Outcome Measures

Vigabatrin levels
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.

Secondary Outcome Measures

Full Information

First Posted
February 23, 2021
Last Updated
February 6, 2023
Sponsor
University of Florida
Collaborators
Yale University, Thomas Jefferson University, American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT04772547
Brief Title
VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
Acronym
VIGAB-STAT
Official Title
VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Yale University, Thomas Jefferson University, American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Epilepticus, Electrographic, Coma
Keywords
post-anoxic status epilepticus, cardiac arrest, nonconvulsive status epilepticus, coma, vigabatrin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
pilot 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.
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open label
Arm Type
Experimental
Arm Description
4500 mg of vigabatrin administered enterally
Intervention Type
Drug
Intervention Name(s)
Vigabatrin Only Product
Other Intervention Name(s)
sabril, vigabatrone
Intervention Description
enteral medication administration, serial blood draws, and outcome assessment
Primary Outcome Measure Information:
Title
Vigabatrin levels
Description
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.
Time Frame
up to day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ralisa Pop, RN
Phone
352-294-5693
Email
Ralisa.Pop@neurology.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Segura
Phone
(352) 733-2412
Email
Julie.Segura@neurology.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina B Maciel, MD, MSCR
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina B Maciel, MD
Phone
352-273-5550
Email
Carolina.Maciel@neurology.ufl.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35067230
Citation
Maciel CB, Teixeira FJP, Dickinson KJ, Spana JC, Merck LH, Rabinstein AA, Sergott R, Shan G, Miao G, Peloquin CA, Busl KM, Hirsch LJ. Early vigabatrin augmenting GABA-ergic pathways in post-anoxic status epilepticus (VIGAB-STAT) phase IIa clinical trial study protocol. Neurol Res Pract. 2022 Jan 24;4(1):4. doi: 10.1186/s42466-022-00168-x.
Results Reference
derived

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VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

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