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

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

Official Title
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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

Conditions
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Epilepsy, Partial

Intervention / Treatment
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* Drug: Seletracetam (UCB44212)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seletracetam<br>Escalating doses twice daily were to be administered. | Drug: Seletracetam (UCB44212)<br>* Pharmaceutical form: oral capsules Concentration: 2, 10 and 50 mg Route of administration: oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period | 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. | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period | 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. | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (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 | 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. | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4) | 
| Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period | 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. | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4) | 
| Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period | 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. | During the Treatment Period (Week 5 to Week 15) | 
| Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period | 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. | During the Treatment Period (Week 5 to Week 15) | 
| Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period | 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. | During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4) | 
| Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period | 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%. | During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4) | 
| Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period | 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). | During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Partial Onset Seizures, Seletracetam, Levetiracetam