NCT Number: NCT00600509
Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method
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.
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Notify MeKey information
Age range
16 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
partial onset seizure frequency per week
Time frame: collection of seizure count throughout the whole study (baseline and treatment periods)
Secondary outcomes
-
safety and tolerability
Time frame: safety and tolerability data were collected throughout the study period
Sponsors and collaborators
Lead sponsor
UCB Pharma
Industry
Collaborators
- UCB Japan Co. Ltd.
Registry information
Official study title
Bridging Study of L059(Levetiracetam) in Patients With Epilepsy by Double Blind Method
Important dates
- Study start
- 2001
- Primary completion
- 2003
- Study completion
- 2003
- First posted
- Jan 25, 2008
- Registry last updated
- Sep 17, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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