Conditions: Infantile Spasms
Keywords: infantile spasms anticonvulsant pediatric epilepsy West Syndrome epileptic spasms
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 54
Healthy volunteers: no

Brief summary:
To allow open-label extension to patients who have completed Protocol 1042-0500

Detailed description:
Patient should have completed all scheduled clinical study visits in the double blind, controlled trial (Protocol 1042-0500) and have been deemed eligible (had a response to treatment) by the Investigator. Male or female, with a diagnosis of IS with a video EEG (vEEG) recording confirming the diagnosis.

There will be a total of 14 visits over 99(+or-1)week. A 24-hr vEEG is only required if the subject has been spasm-free for more than 24-hrs.

Arms:
arm 1: None

Interventions: intervention 1: Ganaxolone
Intervention descriptions: intervention 1: None

Protocol document: