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

Phase 2

Completed

Conditions: Epilepsy, Partial

Interventions: Drug: Seletracetam (UCB44212)

Registration Number: NCT00152503

Lead Sponsor: UCB Pharma SA

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Seletracetam	Seletracetam (UCB44212)	Escalating doses twice daily were to be administered.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period	During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)	Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period	During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)	Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period	During the Treatment Period (Week 5 to Week 15)	Calculated as 7-day partial onset seizure (type I) frequency; The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period	During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)	Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period	During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)	Response to treatment in partial onset seizures (type I) over the up-titration period were analyzed by the percentage change from baseline (Week 1 to Week 4) in partial seizure frequency per week over the up-titration period, grouped in 4 categories: \<-25%, -25% to \<25%, 25% to \<75%, and 75% to 100%.
Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period	During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)	A day was considered seizure-free, if no seizure was reported during 24 hours. A positive value indicates improvement from Baseline (Week 1 to Week 4).
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period	During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)	Calculated as (7-day seizure frequency during the Treatment Period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)), divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial onset seizure frequency from Baseline. The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period	During the Treatment Period (Week 5 to Week 15)	Calculated as 7-day seizure frequency for all seizure types (type I+II+III). The Treatment Period consists of an 8-week Up-Titration Period (Visit 3/Week 5 to Visit 7/Week 12) and a 3-week Down-Titration Period (Visit 7/Week 13 to Visit 10/Week 15). Visit x includes the period from the beginning of Visit x-1 up to but not including Visit x.
Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period	During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)	A responder was defined as a subject with a \>= 50% reduction in seizure frequency per week from the Baseline Period (Week 1 to Week 4) to the end of the Up-Titration Period.