drugset / Trial / NCT00465517

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

NCT00465517

Phase 2 Completed 147 enrolled Marinus Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-02
Primary completion
2008-10
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ganaxolone Small molecule 200 mg Oral
Subject Ganaxolone Small molecule 500 mg Oral

Indications