Conditions: Lennox-Gastaut Syndrome
Keywords: Central Nervous System
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 37
Healthy volunteers: no

Brief summary:
This study was designed to evaluate the cognitive effect, safety, and pharmacokinetics (PK) of rufinamide on Lennox-Gastaut Syndrome (LGS) inadequately controlled in pediatric participants already taking other anti-epileptic drugs.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Rufinamide intervention 2: Any other approved Antiepileptic Drug
Intervention descriptions: intervention 1: Rufinamide up to 45 mg/kg/day, in 2 divided doses, administered as oral suspension (40 mg/mL) as an add-on to the subject's existing regimen of 1-3 antiepileptic drugs (AEDs) intervention 2: Any other approved AED: any other approved AED of the investigator's choice as an add-on to the subject's existing regimen of 1-3 anti-epileptic drugs (AEDs)

Protocol document: