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

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

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)

Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00600509

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

Additional Information: Identifier: NCT00600509     History of Changes
Other Study ID Numbers: N165
Study First Received: January 14, 2008
Last Updated: September 16, 2013

Keywords provided by UCB Pharma:

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs processed this record on June 23, 2017