VIGABatrin in Post-anoxic STATus Epilepticus

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-22

Study Completion Date

2024-01-23

Brief Summary

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

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Detailed Description

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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.

Conditions

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Status Epilepticus, Electrographic Coma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

pilot feasibility trial of pharmacokinetics of drug absorption

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Open label

4500 mg of vigabatrin administered enterally

Group Type EXPERIMENTAL

Vigabatrin Only Product

Intervention Type DRUG

enteral medication administration, serial blood draws, and outcome assessment

Interventions

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Vigabatrin Only Product

enteral medication administration, serial blood draws, and outcome assessment

Intervention Type DRUG

Other Intervention Names

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sabril, vigabatrone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No