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Trial record 1 of 2 for:    NCT00600509
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Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method

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ClinicalTrials.gov Identifier: NCT00600509
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : September 17, 2013
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by:
UCB Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Levetiracetam Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Bridging Study of L059(Levetiracetam) in Patients With Epilepsy by Double Blind Method
Study Start Date : January 2001
Actual Primary Completion Date : July 2003
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. partial onset seizure frequency per week [ Time Frame: collection of seizure count throughout the whole study (baseline and treatment periods) ]

Secondary Outcome Measures :
  1. safety and tolerability [ Time Frame: safety and tolerability data were collected throughout the study period ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600509


Sponsors and Collaborators
UCB Pharma
UCB Japan Co. Ltd.
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
More Information
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ClinicalTrials.gov Identifier: NCT00600509    
Other Study ID Numbers: N165
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2009
Keywords provided by UCB Pharma:
Levetiracetam
Keppra
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Levetiracetam
Anticonvulsants
Nootropic Agents