A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures

Phase 3 Completed 352 enrolled UCB Japan Co. Ltd.

RandomizedParallel-groupTriple-blindTreatment

Summary

A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from partial onset seizures.

Timeline

Start: 2005-11
Primary completion: 2007-11
Completion: 2007-11

Outcome

Missed primary endpoint

paper Unlike the previous trial, the primary efficacy analysis between the levetiracetam 1000 and 3000-mg and placebo groups did not reach statistical significance PMID 25854635 ↗

Publications

Inoue Y, Yagi K, Ikeda A, Sasagawa M, Ishida S, Suzuki A, Yoshida K; Japan Levetiracetam N01221 Study Group. Efficacy and tolerability of levetiracetam as adjunctive therapy in Japanese patients with uncontrolled partial-onset seizures. Psychiatry Clin Neurosci. 2015 Oct;69(10):640-8. doi: 10.1111/pcn.12300. Epub 2015 May 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levetiracetam	Other / unclassified	500 mg	Oral
Subject	Levetiracetam	Other / unclassified	1000 mg	Oral
Subject	Levetiracetam	Other / unclassified	2000 mg	Oral
Subject	Levetiracetam	Other / unclassified	3000 mg	Oral