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

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam

Primary Measures

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

Secondary Measures

• safety and tolerability
  • Time Frame: safety and tolerability data were collected throughout the study period
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: UCB, Inc. Industry

Overall Clinical Trial Officials and Contacts

UCB Clinical Trial Call Center Study Director +1 877 822 9493 (UCB)  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00600509

Study ID Number: N165

ClinicalTrials.gov Identifier: NCT00600509

Health Authority: Japan: Ministry of Health, Labor and Welfare