At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 123 enrolled
Drug / intervention
ganaxolonedrug
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.
An Open-label Extension Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxolone as add-on Therapy in Adult Patients With Epilepsy Consisting of Uncontrolled Partial-onset Seizures.
In Brief
A Phase 2 clinical trial evaluating ganaxolone for Epilepsies, Partial. Completed, enrolled 123 participants across 25 sites.
Detailed Summary
To allow open-label extension to patients who have completed Protocol 1042-0600.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsies, Partial
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedAug 2007
Primary CompletionDec 2009
Study CompletionSep 2013
TodayJul 2026
First PostedAug 7, 2007
Enrollment StartJun 1, 2007
Primary CompletionDec 1, 2009
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.9 years ago
Interventions
ganaxolonedrug
liquid suspension dosed tid