Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method
Phase 2
Completed
- Conditions
- Epilepsy
- Registration Number
- NCT00600509
- Lead Sponsor
- UCB Pharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method partial onset seizure frequency per week collection of seizure count throughout the whole study (baseline and treatment periods)
- Secondary Outcome Measures
Name Time Method safety and tolerability safety and tolerability data were collected throughout the study period