NCT00367432

A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures

A Multicenter, Open, Long-term Follow-up Study to Evaluate the Safety and Efficacy of L059 (Levetiracetam) at Individual Optimal Dose Ranging From 500 to 3000 mg/Day in Twice Daily Administration in Subjects From 16 to 65 Years With Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized Who Completed in a Previous Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 398 (actual)
• Sponsor: UCB Japan Co. Ltd. · Industry
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed N01020 \[NCT00160165\] or N01221 \[NCT00280696\].

Conditions

• Epilepsies
• Partial

Interventions

Type	Name	Description
DRUG	Levetiracetam	Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).

Timeline

• Start date: 2006-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2006-08-22
• Last updated: 2020-11-13
• Results posted: 2012-01-16

Locations

53 sites across 1 country: Japan