Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam

UCB

Status and phase: Completed; Phase 2

Conditions: Epilepsy, Partial

Treatments: Drug: Seletracetam (UCB44212)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00152503

N01192

Details and patient eligibility

About

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

Enrollment: 59 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 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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

59 participants in 1 patient group

Seletracetam

Experimental group

Description:

Escalating doses twice daily were to be administered.

Treatment:

Drug: Seletracetam (UCB44212)