Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method

Bridging Study of L059(Levetiracetam) in Patients With Epilepsy by Double Blind Method

Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with partial onset seizures.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: Levetiracetam

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• simple and/or complex partial seizures with or without secondary generalization, and first partial seizure >= 2 years before selection visit;
• seizures classifiable according to the ILAE classification;
• minimum of 12 partial seizures per 12 weeks with a minimum of two partial seizures per 4 weeks from the selection visit to the end of the baseline period ;
• exposed to two or more standard AEDs;
• taking up to three of the standard AEDs, at the initiation of the trial.

Exclusion Criteria:

• medication influencing the CNS, except for medication taken for antiepileptic treatment;
• partial seizures uncountable due to clustering, including status epileptics, during the 3 months prior to the selection visit;
• history of cerebrovascular disease including transient ischemic attack (TIA) and progressive cerebral disorder or progressive neurological disorder;
• presence or history of any clinically significant allergic condition and complication or history of significant alcohol abuse or drug abuse in the past.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
partial onset seizure frequency per week	collection of seizure count throughout the whole study (baseline and treatment periods)

Secondary Outcome Measures

Outcome Measure	Time Frame
safety and tolerability	safety and tolerability data were collected throughout the study period

Collaborators and Investigators

• Sponsor: UCB Pharma
• Collaborators: UCB Japan Co. Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): July 1, 2003
• Study Completion (Actual): July 1, 2003

Study Registration Dates

• First Submitted: January 14, 2008
• First Submitted That Met QC Criteria: January 14, 2008
• First Posted (Estimate): January 25, 2008

Study Record Updates

• Last Update Posted (Estimate): September 17, 2013
• Last Update Submitted That Met QC Criteria: September 16, 2013
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Levetiracetam; Keppra
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Anticonvulsants; Nootropic Agents; Levetiracetam
• Other Study ID Numbers: N165