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

This study has been completed.
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00600509
First received: January 14, 2008
Last updated: September 16, 2013
Last verified: September 2009
  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:


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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600509

Sponsors and Collaborators
UCB, Inc.
UCB Japan Co. Ltd.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional 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 16, 2013
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 April 16, 2014