At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 enrolled
Drug / intervention
IV Ganaxolone active +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 Safety, Tolerability, Efficacy, and Pharmacokinetics of Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
In Brief
A Phase 2 clinical trial evaluating IV Ganaxolone active and IV Placebo, non-active for Status Epilepticus and 3 related conditions. Completed, enrolled 17 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStatus Epilepticus, Convulsive Status EPILEPTICUS, Non Convulsive Status Epilepticus, Epilepsy
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 2017
Enrollment StartFeb 2018
Primary CompletionSep 2019
TodayJul 2026
First PostedNov 22, 2017
Enrollment StartFeb 19, 2018
Primary CompletionSep 18, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.6 years ago
Interventions
IV Ganaxolone activedrug
IV
IV Placebo, non-activedrug
IV