At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 100 enrolled
Drug / intervention
Ganaxolone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus
In Brief
A Phase 3 clinical trial evaluating Ganaxolone and Placebo for Status Epilepticus. Completed, enrolled 100 participants across 74 sites in 3 countries.
Detailed Summary
This study evaluated the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStatus Epilepticus
CountriesAustralia, Canada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedMay 2020
Enrollment StartDec 2020
Primary CompletionMar 2024
Study CompletionApr 2024
TodayJul 2026
First PostedMay 18, 2020
Enrollment StartDec 9, 2020
Primary CompletionMar 30, 2024
Study CompletionApr 28, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.1 years ago
Interventions
Ganaxolonedrug
Ganaxolone will be administered.
Placebodrug
Placebo will be administered.