Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method
This study has been completed.
Sponsor:
UCB, Inc.
Collaborator:
UCB Japan Co. Ltd.
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00600509
First received: January 14, 2008
Last updated: September 9, 2009
Last verified: September 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: Levetiracetam |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Bridging Study of L059(Levetiracetam) in Patients With Epilepsy by Double Blind Method |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Levetiracetam
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- partial onset seizure frequency per week [ Time Frame: collection of seizure count throughout the whole study (baseline and treatment periods) ]
Secondary Outcome Measures:
- safety and tolerability [ Time Frame: safety and tolerability data were collected throughout the study period ]
| Enrollment: | 216 |
| Study Start Date: | January 2001 |
| Study Completion Date: | July 2003 |
| Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00600509 History of Changes |
| Other Study ID Numbers: | N165 |
| Study First Received: | January 14, 2008 |
| Last Updated: | September 9, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by UCB, Inc.:
|
Levetiracetam Keppra |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Etiracetam Piracetam Anticonvulsants |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013