Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures

Launched by UCB S.A. - PHARMA SECTOR · Sep 8, 2005

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)
• • Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized
• • Subjects who have been treated for epilepsy for \>=6 months and are currently uncontrolled while being treated with 1-3 concomitant Antiepileptic Drug (AEDs)
• • Female subjects without childbearing potential; Female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method
• Exclusion Criteria:
• • Seizures occurring in clusters.
• • Status epilepticus within 6 months of Visit 1
• • History of non-epileptic seizures
• • Subjects on vigabatrin
• • Subjects on felbamate, unless treatment has been continuous for \>2 years
• • Ongoing psychiatric disease other than mild controlled disorders.
• • Subjects with clinically significant organ dysfunction
• • Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
• • Pregnant or lactating women
• • Subjects currently taking levetiracetam (LEV)
• • Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant Antiepileptic Drug (AEDs)