NCT01398956

An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures

An Open-label, Multicenter, Long-term, Follow-up Study in Japan to Evaluate the Safety, Tolerability, and Efficacy of Adjunctive Treatment With Oral L059 (Levetiracetam) in Epilepsy Subjects With Generalized Tonic-clonic (GTC) Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.

Conditions

• Epilepsy
• Generalized Tonic-clonic Seizures

Interventions

Type	Name	Description
DRUG	Levetiracetam	formulation: tablet or dry syrup strength: 250 mg tablet, 500 mg tablet, dry syrup 50% dosage: Sb ≥16 years and ≥4 and \<16 years (≥50 kg): 1000 mg/day, 2000 mg/day or 3000 mg/day; Sb ≥4 and \<16 years (\<50kg): 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day frequency: twice daily

Timeline

• Start date: 2011-06-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2011-07-21
• Last updated: 2017-08-15
• Results posted: 2017-03-09

Locations

32 sites across 1 country: Japan