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

UCB

Status and phase

Completed

Phase 2

Conditions

Epilepsy, Partial

Treatments

Drug: Seletracetam (ucb 44212)

Study type

Interventional

Funder types

Industry

Identifiers

N01191

Details and patient eligibility

About

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

Enrollment

31 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)