A Phase 2 interventional study of Vigabatrin Only Product in Status Epilepticus, Electrographic and Coma, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by University of Florida · Phase 2, Interventional, and Treatment
This is a pilot trial of a single loading dose of vigabatrin in post-anoxic status epilepticus.
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.
126 studies on the registry are indexed under Status Epilepticus; 37 are open to participants now.
This study's enrollment of 6 is below the median of 70 across 74 interventional studies indexed under Status Epilepticus.
Browse Status Epilepticus studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
4500 mg of vigabatrin administered enterally
Drug: Vigabatrin Only Product
enteral medication administration, serial blood draws, and outcome assessment
Also known as: sabril, vigabatrone
Primary Pharmacologic Outcome - Absorption
By analyzing serial vigabatrin levels including baseline, we characterized vigabatrin absorption; the target was to achieve a detectable vigabatrin level in the serum of ≥ 80% of enrolled subjects by 3 hours post-load.
Time frame: 3h
Primary Feasibility Outcome - Enrollment and Drug Delivery
We looked at the ability to deliver vigabatrin within 48 hours of PASE onset in ≥ 80% of enrolled subjects. Vigabatrin dose was adjusted according to renal functioning (CrCl\>50 ml/min: 4500 mg, CrCl 30-50 ml/min: 2250 mg, CrCl\<30 ml/min: 1125 mg)
Time frame: 48 hours
Primary Feasibility Outcome - Visual Screening (Goldmann Perimetry)
We planned to obtain Goldmann perimetry testing in the subjects who could cooperate at the 6 months follow-up. Our goal was to have reliable visual field perimetry in ≥ 80% of survivors who regained consciousness following index hospitalization.
Time frame: 6 months
Primary Feasibility Outcome - Participants With Visual Screening for Taurine Levels
We obtained serial taurine levels during ICU stay at time 0h, 72h and 168h following vigabatrin administration. Our goal was to achieve a 90% completion rate for taurine levels.
Time frame: 0h, 72h and 168h following vigabatrin administration
Ultra-early Vigabatrin Administration
We tracked the proportion of enrolled subjects who received a vigabatrin load within 12 and 24 hours of PASE onset to explore the possibility of ultra-early administration of vigabatrin in subsequent phases.
Time frame: 0h to 48h after vigabatrin admnistration
Secondary Pharmacologic Outcome: Elimination
By analyzing serial VGB levels, we characterized drug elimination. We anticipated subjects with normal renal function would have undetectable vigabatrin levels by 72 hours, and those with creatinine clearance less than 30 mL/min would have detectable VGB levels at 72 hours. We anticipated undetectable vigabatrin levels in all subjects by 7 days regardless of their renal function.
Time frame: 72h and 7 days following vigabatrin administration
PASE Onset Detection
We tracked the proportion of subjects in whom PASE was present upon connection to EEG (onset misses) to explore alternatives to allow prompt EEG monitoring following the return of spontaneous circulation (ROSC).
Time frame: Determined at the time of connection to EEG monitoring
The study recruitment occurred from September 2021 until June 2023 at the University of Florida, Shands Hospital. All patients with cardiac arrest requiring continuous EEG (cEE) monitoring were screened for eligibility.
| Milestone | Open Label |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
By analyzing serial vigabatrin levels including baseline, we characterized vigabatrin absorption; the target was to achieve a detectable vigabatrin level in the serum of ≥ 80% of enrolled subjects by 3 hours post-load.
| Participants | Open Label |
|---|---|
| Detectable drug level 3h post-administration | 6 |
| Undetectable drug level 3h post-administration | 0 |
We looked at the ability to deliver vigabatrin within 48 hours of PASE onset in ≥ 80% of enrolled subjects. Vigabatrin dose was adjusted according to renal functioning (CrCl\>50 ml/min: 4500 mg, CrCl 30-50 ml/min: 2250 mg, CrCl\<30 ml/min: 1125 mg)
| Participants | Open Label |
|---|---|
| Vigabatrin administered within 48h of PASE onset | 6 |
| Vigabatrin not administered within 48h of PASE onset | 0 |
We planned to obtain Goldmann perimetry testing in the subjects who could cooperate at the 6 months follow-up. Our goal was to have reliable visual field perimetry in ≥ 80% of survivors who regained consciousness following index hospitalization.
No measurements were reported for this outcome.
We obtained serial taurine levels during ICU stay at time 0h, 72h and 168h following vigabatrin administration. Our goal was to achieve a 90% completion rate for taurine levels.
| Participants | Open Label |
|---|---|
| Taurine levels collected at 0h | 6 |
| Taurine levels collected at 72h | 4 |
| Taurine levels collected at 168h | 1 |
We tracked the proportion of enrolled subjects who received a vigabatrin load within 12 and 24 hours of PASE onset to explore the possibility of ultra-early administration of vigabatrin in subsequent phases.
| Participants | Open Label |
|---|---|
| within 12h of PASE onset | 1 |
| within 12-24h of PASE onset | 3 |
| within 24-48h of PASE onset | 2 |
By analyzing serial VGB levels, we characterized drug elimination. We anticipated subjects with normal renal function would have undetectable vigabatrin levels by 72 hours, and those with creatinine clearance less than 30 mL/min would have detectable VGB levels at 72 hours. We anticipated undetectable vigabatrin levels in all subjects by 7 days regardless of their renal function.
| Participants | Open Label |
|---|---|
| Undetectable vigabatrin concentration at 72h | 2 |
| Detectable vigabatrin concentration at 72h | 2 |
| Undetectable vigabatrin concentration at 7 days | 2 |
| Detectable vigabatrin concentration at 7 days | 0 |
We tracked the proportion of subjects in whom PASE was present upon connection to EEG (onset misses) to explore alternatives to allow prompt EEG monitoring following the return of spontaneous circulation (ROSC).
| Participants | PASE Onset Misses |
|---|---|
| PASE Onset Detection | 8 |
Collected over As per clinical trial protocol, all subjects were monitored daily for adverse (AE) and serious adverse events (SAE) from the time of enrollment for the duration of their ICU stay. The PI monitored patient safety data within 24 hours of AE's or SAE's. The duration of ICU stay for the subjects was approximately 1 week. Screening for visual AE's was planned at the 6-month follow-up visit. Due to inpatient mortality, none of the enrolled subjects completed the 6-month follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open Label | 6/6 (100%) | 0/6 (0%) | 0/6 (0%) |
| Age, Continuous(years) | Open Label |
|---|---|
| Median | 62 (22 to 68) |
| Sex: Female, Male(Participants) | Open Label |
|---|---|
| Female | 2 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Open Label |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Open Label |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Open Label |
|---|---|
| United States | 6 |
| BMI(kg/m^2) | Open Label |
|---|---|
| Mean | 33.22 ± 13.11 |
| Creatinine Clearance (CrCl)(Participants) | Open Label |
|---|---|
| CrCl >50 ml/min | 2 |
| CrCl 30-50 ml/min | 2 |
| CrCl <30 ml/min | 2 |
| Weight(kg) | Open Label |
|---|---|
| Mean | 88.03 ± 32.12 |
1 further baseline measures are reported on the registry.
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University of Florida