At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 405 enrolled
Drug / intervention
ganaxolone +1 moredrug
Likely dose
ganaxolone 200 mgfrom 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 Multicenter, Double Blind, Randomized, Placebo-Controlled Trial to Determine the Efficacy and Safety of Ganaxolone as Adjunctive Therapy for Adults With Drug-Resistant Partial-Onset Seizures Followed by Long-term Open-Label Treatment
In Brief
A Phase 3 clinical trial evaluating ganaxolone and Placebo for Drug Resistant Partial Onset Seizure. Completed, enrolled 405 participants across 71 sites in 6 countries.
Detailed Summary
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Resistant Partial Onset Seizure
CountriesAustralia, Bulgaria, Germany, Poland, Russia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedOct 2013
Primary CompletionMay 2016
Study CompletionOct 2016
TodayJul 2026
First PostedOct 16, 2013
Enrollment StartOct 1, 2013
Primary CompletionMay 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.7 years ago
Interventions
ganaxolonedrug
200 mg and 225 mg capsules; target dose 1800 mg/day dosed 900mg 2x/day
Placebodrug
placebo