Status Epilepticus, ElectrographicPhase 2VIGAB-STATNCT04772547
VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
A Phase 2 study testing Vigabatrin Only Product in people with Status Epilepticus, Electrographic and Coma, run by University of Florida at 1 site in United States.
Trial summary
This is a pilot trial of a single loading dose of vigabatrin in post-anoxic status epilepticus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Status Epilepticus, Electrographic, Coma
- What is being tested?
- Vigabatrin Only Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to 23 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- prior history of generalized epilepsy
- history of gastrointestinal surgery within the last 21 days
- pregnancy
- status epilepticus onset preceding initiation of electroencephalography monitoring
Trial locations and contacts
1 site in 1 country.
About this study
This is a pilot trial of a single loading dose of vigabatrin in post-anoxic status epilepticus.
Read the 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.
- Conditions
- Status Epilepticus, Electrographic, Coma
- Being tested
- Vigabatrin Only Product
- Keywords
- post-anoxic status epilepticus, cardiac arrest, nonconvulsive status epilepticus, coma, vigabatrin
- Medical subject headings
- Status Epilepticus, Coma, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigabatrin Only ProductDrug
Also called sabril, vigabatrone
enteral medication administration, serial blood draws, and outcome assessment
| Study group | Role | What they receive |
|---|---|---|
| Open label | Experimental | 4500 mg of vigabatrin administered enterally Receives: Drug: Vigabatrin Only Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 0h, 72h and 168h following vigabatrin administration
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: Determined at the time of connection to EEG monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start22 Sep 2021
- Primary completion7 Jun 2023
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Status Epilepticus, ElectrographicStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pilot feasibility trial of pharmacokinetics of drug absorption
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Thomas Jefferson University, American Heart Association
- Responsible party
- Sponsor
- Investigators
- Carolina B Maciel, MD, MSCR, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772547
- Sponsor's protocol ID
- VIGAB-STAT IIa
- Other IDs
- IRB202003076, OCR40379, PRO00031111, 20IPA35380013
- Acronym
- VIGAB-STAT
- Status last verified
- Jul 2024
- First submitted
- 23 Feb 2021
- Last updated
- 23 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35067230
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa
- ClinicalTrials.gov ID
- NCT04772547
- Acronym / sponsor ID
- VIGAB-STAT / VIGAB-STAT IIa
- Conditions
- Status Epilepticus, Electrographic, Coma
- Keywords
- post-anoxic status epilepticus, cardiac arrest, nonconvulsive status epilepticus, coma, vigabatrin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Yale University, Thomas Jefferson University, American Heart Association
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Posted 12 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot feasibility trial of pharmacokinetics of drug absorption
| Arm | Type | Receives |
|---|---|---|
| Open label | Experimental | Drug: Vigabatrin Only Product4500 mg of vigabatrin administered enterally |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- prior history of generalized epilepsy
- history of gastrointestinal surgery within the last 21 days
- pregnancy
- status epilepticus onset preceding initiation of electroencephalography monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vigabatrin Only ProductAlso: sabril, vigabatroneenteral medication administration, serial blood draws, and outcome assessment | Drug | Open label |
Primary outcome
Primary Pharmacologic Outcome - Absorption
Time frame: 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 Feasibility Outcome - Enrollment and Drug Delivery
Time frame: 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 Feasibility Outcome - Visual Screening (Goldmann Perimetry)
Time frame: 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 Feasibility Outcome - Participants With Visual Screening for Taurine Levels
Time frame: 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.
3 secondary outcomes
Ultra-early Vigabatrin Administration
Time frame: 0h to 48h after vigabatrin admnistration
Secondary Pharmacologic Outcome: Elimination
Time frame: 72h and 7 days following vigabatrin administration
PASE Onset Detection
Time frame: Determined at the time of connection to EEG monitoring
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35067230Maciel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina B Maciel, MD, MSCR principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vigabatrin Only Product in people with Status Epilepticus, Electrographic and Coma, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Pharmacologic Outcome - Absorption (time frame: 3h). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04772547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.