ON GOING TRIALS, NOT ENROLLING - 1

MARINUS GANAXOLONE

Protocol Number: 1042-0603

4. A Multicenter, Double Blind, Randomized, Placebo-Controlled Trial to Determine the Efficacy and Safety of Ganaxolone as Adjunctive Therapy for Adults with Drug-Resistant Partial-Onset Seizures Followed by Long-term Open-Label Treatment

Study Design:

4-week prospective baseline period plus 4 week retrospective baseline followed by two treatment phases: a 9-week randomized DB placebo-controlled treatment phase followed by a 52-week open label (OL) treatment phase

Primary Inclusion Criteria
• Age 18 years of age and older
• Diagnosis of epilepsy with POS with or without secondary generalization
• Frequency rate of 3 POS during the 4-week prospective baseline phase and unlikely to have a period of 21 consecutive POS-free days
• Currently treatment with 1 to 3 AEDs for ≥1 month prior to screening
• If on barbiturates (e.g. phenobarbital), dose must be stable for ≥3 months prior to screening
• Chronic use of a benzodiazepine as a concurrent AED is permitted if dose is stable for 1month prior to the screening visit 

Primary Exclusion Criteria
• Generalized epilepsy
• Innumerable seizures or status epilepticus within the last 12-months prior to screening
• Time of onset of epilepsy treatment < 2 years prior to enrollment
• Use of benzodiazepines as rescue for innumerable seizure clusters during 4-week baseline period