An Open-label, Exploratory, Multicenter, Dose-escalation Study Examining the Efficacy, Safety and Tolerability of Ucb 44212 Used at Doses of 10 mg, 20 mg, 40 mg and 80 mg b.i.d. (Total Daily Dose of 20 to 160 mg) in Adult Subjects (18-65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures (Whether or Not Secondarily Generalized) and Treated With 1, 2 or 3 Approved Antiepileptic Drugs

N01191

This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.

2005-05-19

2006-05-03

2006-05-03

Completed

Early phase I

31

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 31, 'type': 'ACTUAL'}}

2024-03-29