Clobazam in Patients With Lennox-Gastaut Syndrome

Inclusion Criteria:

• Patient must have been <11 years of age at the onset of LGS.

• Patient must have LGS.

• Patient must be on at least 1 AED.

• Parent or caregiver must be able to keep an accurate seizure diary.

Exclusion Criteria:

• Etiology of patient's seizures is a progressive neurologic disease. Patients withtuberous sclerosis will not be excluded from study participation, unless there is aprogressive tumor.

• Patient has had an episode of status epilepticus within 12 weeks of baseline.

• Patient has had an anoxic episode requiring resuscitation within 6 months ofscreening.

• Patient has a clinically significant history of an allergic reaction or significantsensitivity to benzodiazepines.

• Patient is taking more than 3 concurrent AEDs.

• Patient has been on the ketogenic diet for less than 30 days prior to screening orsuffers from frequent stooling.

• If the patient has a Vagal Nerve Stimulator (VNS), the settings have not been stablefor at least 30 days prior to screening.

• Patient has taken corticotropins in the 6 months prior to screening.

• Patient is currently taking long-term systemic steroids (excluding inhaled mediationfor asthma treatment) or any other daily medication known to exacerbate epilepsy. Anexception will be made of prophylactic medication, for example, for idiopathicnephrotic syndrome or asthma.

• If the patient is taking felbamate, has been taking it for less than 1 year prior toscreening. Other protocol-defined inclusion and exclusion criteria may apply.