NCT01405053

Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs

A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 1 Year – 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lennox-Gastaut Syndrome

Interventions

Type	Name	Description
DRUG	Rufinamide	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)
DRUG	Any other approved Antiepileptic Drug	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)

Timeline

• Start date: 2011-06-16
• Primary completion: 2015-11-02
• Completion: 2015-11-02
• First posted: 2011-07-29
• Last updated: 2019-08-06
• Results posted: 2019-08-06

Locations

47 sites across 7 countries: United States, Canada, France, Greece, Italy, Poland, South Africa