NCT01146951

A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)

A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Eisai Limited · Industry
• Sex: All
• Age: 4 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome.

Conditions

• Lennox-Gastaut Syndrome

Interventions

Type	Name	Description
DRUG	Rufinamide (E2080)	Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
DRUG	Placebo	Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-06-22
• Last updated: 2018-01-24
• Results posted: 2013-11-21

Locations

23 sites across 1 country: Japan