An Open Label, Exploratory, Dose-escalation, Multicenter Study Examining the Safety, Tolerability and Efficacy of Ucb 44212 (Seletracetam) Used at Doses of 10, 20, 40, and 80 mg b.i.d. (Total Daily Doses of 20 - 160 mg) Administration (Oral Capsules) in Adult Subjects (18 - 65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures Who Are Currently Receiving Levetiracetam (LEV) But Still Experiencing Seizures

N01192

This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.

2005-08-31

2006-05-12

2006-05-12

Completed

Early phase I

59

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 AED(s), inclusive of levetiracetam (LEV) * Female subjects without childbearing potential or those who are using an acceptable 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 * 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': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 59, 'type': 'ACTUAL'}}

2023-09-07