Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: Levetiracetam (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)
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.
Clinical Details
Official title: Bridging Study of L059(Levetiracetam) in Patients With Epilepsy by Double Blind Method
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: partial onset siezure frequency per week
Secondary outcome: safety and tolerability
Eligibility
Minimum age: 16 Years.
Maximum age: 65 Years.
Gender(s): Both.
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 epilepticus, 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.
Locations and Contacts
Additional Information
Starting date: January 2001
Ending date: July 2003
Last updated: March 7, 2008
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