Clinical trial
A Double-Blind Randomized, Placebo Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
Name
1042-SE-2001
Description
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.
Trial arms
Trial start
2018-02-19
Estimated PCD
2019-09-18
Trial end
2019-09-18
Status
Completed
Phase
Early phase I
Treatment
IV Ganaxolone active
IV
Arms:
IV Ganaxolone active
IV Placebo, non-active
IV
Arms:
IV Placebo, non-active
Size
17
Primary endpoint
Number of Participants Who Did Not Require an IV Anesthetic Drug for SE Treatment
24 hours post study drug initiation
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind study that will randomize subjects to ganaxolone or placebo in a 1:1 ratio as adjunctive therapy to their standard of care.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 17, 'type': 'ACTUAL'}}
Updated at
2023-03-09
1 organization
2 products
4 indications
Organization
Marinus PharmaceuticalsProduct
GanaxoloneIndication
Status EpilepticusIndication
Convulsive Status EpilepticusIndication
Nonconvulsive Status EpilepticusIndication
EpilepsyProduct
IV Placebo