NCT00465517

A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Marinus Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Partial Epilepsy
• Catamenial Epilepsy

Interventions

Type	Name	Description
DRUG	Ganaxolone	Oral suspension 200-500 mg 3x/day
OTHER	Placebo	non-active placebo

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-10-01
• Completion: 2008-11-01
• First posted: 2007-04-25
• Last updated: 2023-03-15
• Results posted: 2023-03-15

Locations

27 sites across 1 country: United States