NCT01228747

A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)

A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Oral Levetiracetam, in Epilepsy Patients Aged ≥16 Years, With Generalized Tonic-clonic (GTC) Seizures

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 361 (actual)
• Sponsor: UCB Japan Co. Ltd. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with 1 or 2 anti-epileptic drugs.

Conditions

• Epilepsy
• Generalized Tonic-Clonic Seizures

Interventions

Type	Name	Description
DRUG	Levetiracetam	Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks
DRUG	Placebo	Matching oral placebo tablets twice daily for 28 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2010-10-26
• Last updated: 2025-04-03
• Results posted: 2015-05-13

Locations

58 sites across 2 countries: China, Japan