Clinical trial NCT04772547: VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
Official title: VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Status Epilepticus, Electrographic
Coma
Keywords: post-anoxic status epilepticus, cardiac arrest, nonconvulsive status epilepticus, coma, vigabatrin
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Yale University
name: Thomas Jefferson University
name: American Heart Association
First posted: 2021-02-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pilot feasibility trial of pharmacokinetics of drug absorption
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary Pharmacologic Outcome - Absorption
timeFrame: 3h
measure: Primary Feasibility Outcome - Enrollment and Drug Delivery
timeFrame: 48 hours
measure: Primary Feasibility Outcome - Visual Screening (Goldmann Perimetry)
timeFrame: 6 months
measure: Primary Feasibility Outcome - Participants With Visual Screening for Taurine Levels
timeFrame: 0h, 72h and 168h following vigabatrin administration
Secondary outcomes:
measure: Ultra-early Vigabatrin Administration
timeFrame: 0h to 48h after vigabatrin admnistration
measure: Secondary Pharmacologic Outcome: Elimination
timeFrame: 72h and 7 days following vigabatrin administration
measure: PASE Onset Detection
timeFrame: Determined at the time of connection to EEG monitoring
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Carolina B Maciel, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References:
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.