Back to resultsBridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Levetiracetam, Keppra
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
partial onset seizure frequency per week
Secondary Outcome Measures
safety and tolerability
Full Information
NCT ID
NCT00600509
First Posted
January 14, 2008
Last Updated
September 16, 2013
Sponsor
UCB Pharma
Collaborators
UCB Japan Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00600509
Brief Title
Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method
Official Title
Bridging Study of L059(Levetiracetam) in Patients With Epilepsy by Double Blind Method
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
July 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
Collaborators
UCB Japan Co. Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Levetiracetam, Keppra
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Primary Outcome Measure Information:
Title
partial onset seizure frequency per week
Time Frame
collection of seizure count throughout the whole study (baseline and treatment periods)
Secondary Outcome Measure Information:
Title
safety and tolerability
Time Frame
safety and tolerability data were collected throughout the study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method
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