Phase 2
N=17
Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
Status Epilepticus · Convulsive Status EPILEPTICUS · Non Convulsive Status Epilepticus · Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT03350035 ↗Enrolled (actual)
17
Serious AEs
35.3%
Results posted
Dec 2022
Primary outcome: Primary: Number of Participants Who Did Not Require an IV Anesthetic Drug for SE Treatment — 5; 4; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IV Ganaxolone active (Drug); IV Placebo, non-active (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Marinus Pharmaceuticals
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Did Not Require an IV Anesthetic Drug for SE Treatment |
5; 4; 8 | — |
| SECONDARY Time to Cessation of SE |
5.000; 5.580; 10.16 | — |
| SECONDARY Number of Participants Who Required No Escalation of Treatment for Ongoing or Recurrent SE |
3; 3; 8 | — |
| SECONDARY Number of Participants With No SE Recurrence Per Principal Investigator |
5; 4; 7; 3; 4; 7 | — |
| SECONDARY Seizure Burden |
-94.80; -74.63; -84.01; -98.59; -71.75; -87.99 | — |
Summary
This study will evaluate the effectiveness and safety of an investigational drug, IV ganaxolone, as adjunctive therapy to standard of care to treat subjects with status epilepticus.
Eligibility Criteria
Inclusion Criteria
- Subjects 12 years of age and older
- Clinical and/or electrographic seizures
Exclusion Criteria
- Life expectancy of less than 24 hours
- Anoxic brain injury as primary cause of SE
- Recent (<24 hour) traumatic brain injury as the primary cause of SE
- Administered anesthesia for the treatment of SE
Data sourced from ClinicalTrials.gov (NCT03350035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.