At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 11 enrolled
Drug / intervention
ganaxolonedrug
Likely dose
ganaxolone 50 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 Treatment Protocol for Ganaxolone as add-on Therapy in Adult Patients With Uncontrolled Partial-onset Seizures Deriving Benefit From Protocol 1042-0601
In Brief
A Phase 2 clinical trial evaluating ganaxolone for Epilepsy, Complex Partial. Completed, enrolled 11 participants across 7 sites.
Detailed Summary
This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Complex Partial
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedOct 2009
Primary CompletionOct 2010
Study CompletionAug 2013
TodayJul 2026
First PostedOct 27, 2009
Enrollment StartOct 1, 2009
Primary CompletionOct 1, 2010
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.7 years ago
Interventions
ganaxolonedrug
liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year