Trial · NCT04772547
VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
NCT04772547, Phase 2, Completed, University of Florida; results first posted 2024-07-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa. Trials, record NCT04772547. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04772547
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
- NCT number
- NCT04772547
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Status Epilepticus, Electrographic, Coma
- Interventions
- Vigabatrin Only Product
- First posted
- 2021-02-26
- Last updated
- 2024-07-23
- Results first posted
- 2024-07-12
- Limitations and caveats
We could not characterize the exploratory safety outcome in our subjects. We aimed to detect rates of retinopathy on vision loss screening via Goldmann perimetry upon regain of consciousness, ICU discharge, and 6 months, in addition to long-term visual screening at 6 months via Visual Function Questionnaire 25 (VFQ-25). However, all six patients enrolled in the trial did not regain consciousness or survive through the follow-up period. So, the assessments could not be performed.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Pharmacologic Outcome - Absorption | 3h | 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. |
| Primary | Primary Feasibility Outcome - Enrollment and Drug Delivery | 48 hours | 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) |
| Primary | Primary Feasibility Outcome - Visual Screening (Goldmann Perimetry) | 6 months | 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. |
| Primary | Primary Feasibility Outcome - Participants With Visual Screening for Taurine Levels | 0h, 72h and 168h following vigabatrin administration | 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. |
| Secondary | Ultra-early Vigabatrin Administration | 0h to 48h after vigabatrin admnistration | 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. |
| Secondary | Secondary Pharmacologic Outcome: Elimination | 72h and 7 days following vigabatrin administration | 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. |
| Secondary | PASE Onset Detection | Determined at the time of connection to EEG monitoring | 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). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Pharmacologic Outcome - Absorption | 3h | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Primary Feasibility Outcome - Enrollment and Drug Delivery | 48 hours | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Primary Feasibility Outcome - Visual Screening (Goldmann Perimetry) | 6 months | The 6 month follow-up could not be completed for any of the 6 enrolled subjects due to in-hospital mortality | ||
| PRIMARY | Primary Feasibility Outcome - Participants With Visual Screening for Taurine Levels | 0h, 72h and 168h following vigabatrin administration | At the 72h timepoint following vigabatrin administration, data for only 5 of the six subjects was analyzed due to the death of one subject before the 72h timepoint. At 168h, data for only 2 of the six subjects was analyzed due to death of four subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Ultra-early Vigabatrin Administration | 0h to 48h after vigabatrin admnistration | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Secondary Pharmacologic Outcome: Elimination | 72h and 7 days following vigabatrin administration | 72 hours after vigabatrin administration, vigabatrin concentration draws were done for only 4 of the 6 subjects, due to the death of 2 subjects. Both the subjects that died had CrCl\<30 ml/min. All 4 of the subjects analyzed had CrCl\>30 ml/min. Therefore, the results could not be stratified based on creatinine clearance level.~7 days after vigabatrin administration, vigabatrin concentration draws were completed for only 2 of the six subjects, due to the death of the other 4 subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PASE Onset Detection | Determined at the time of connection to EEG monitoring | The study did not enroll patients with PASE onset preceding the initiation of EEG monitoring. However, as a secondary exploratory outcome, we characterized the number of PASE-onset misses by determining the number of screen-failed patients, whose reason for screen failure was PASE onset preceding EEG monitoring initiation. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Pharmacologic Outcome - Absorption | Open Label | Detectable drug level 3h post-administration | 6 | Participants | |
| Primary Pharmacologic Outcome - Absorption | Open Label | Undetectable drug level 3h post-administration | 0 | Participants | |
| Primary Feasibility Outcome - Enrollment and Drug Delivery | Open Label | Vigabatrin administered within 48h of PASE onset | 6 | Participants | |
| Primary Feasibility Outcome - Enrollment and Drug Delivery | Open Label | Vigabatrin not administered within 48h of PASE onset | 0 | Participants | |
| Primary Feasibility Outcome - Participants With Visual Screening for Taurine Levels | Open Label | Taurine levels collected at 0h | 6 | Participants | |
| Primary Feasibility Outcome - Participants With Visual Screening for Taurine Levels | Open Label | Taurine levels collected at 72h | 4 | Participants | |
| Primary Feasibility Outcome - Participants With Visual Screening for Taurine Levels | Open Label | Taurine levels collected at 168h | 1 | Participants | |
| Ultra-early Vigabatrin Administration | Open Label | within 12h of PASE onset | 1 | Participants | |
| Ultra-early Vigabatrin Administration | Open Label | within 12-24h of PASE onset | 3 | Participants | |
| Ultra-early Vigabatrin Administration | Open Label | within 24-48h of PASE onset | 2 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open Label | 6 | |
| Overall Study | COMPLETED | Open Label | 6 | |
| Overall Study | NOT COMPLETED | Open Label | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open Label | 6 | 6 |
| Total, other adverse events | Open Label | 0 | 6 |
| Total, serious adverse events | Open Label | 0 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35067230 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04772547
GET https://conductscience.org/api/trials/v1/NCT04772547/registered