At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxolone as add-on Therapy in Adult Subjects With Epilepsy Consisting of Uncontrolled Partial-onset Seizures.
In Brief
A Phase 2 clinical trial evaluating Ganaxolone and Placebo for Partial Epilepsy and Catamenial Epilepsy. Completed, enrolled 147 participants across 27 sites.
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). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy. Catamenial epilepsy refers to a relationship between seizure frequency and a woman's menstrual cycle, where the number of seizures increases around the time of a woman's menstrual cycle.
Study Details
Timeline
Interventions
Oral suspension 200-500 mg 3x/day
non-active placebo