Back to resultsStudy With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
Primary Purpose
Epilepsy, Partial
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Seletracetam (UCB44212)
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy, Partial focused on measuring Epilepsy, Partial Onset Seizures, Seletracetam, Levetiracetam
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Seletracetam
Arm Description
Escalating doses twice daily were to be administered.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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%.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00152503
Brief Title
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 31, 2005 (Actual)
Primary Completion Date
May 12, 2006 (Actual)
Study Completion Date
May 12, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial
Keywords
Epilepsy, Partial Onset Seizures, Seletracetam, Levetiracetam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Seletracetam
Arm Type
Experimental
Arm Description
Escalating doses twice daily were to be administered.
Intervention Type
Drug
Intervention Name(s)
Seletracetam (UCB44212)
Intervention Description
Pharmaceutical form: oral capsules
Concentration: 2, 10 and 50 mg
Route of administration: oral administration
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Description
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.
Time Frame
During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Description
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.
Time Frame
During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Title
Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit and Overall by Period
Description
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.
Time Frame
During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Title
Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I + II + III) by Visit and Overall by Period
Description
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.
Time Frame
During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
Title
Seizure Frequency Per Week (Type I) by Visit Over the Treatment Period and Overall by Period
Description
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.
Time Frame
During the Treatment Period (Week 5 to Week 15)
Title
Seizure Frequency Per Week (Type I+II+III) by Visit Over the Treatment Period and Overall by Period
Description
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.
Time Frame
During the Treatment Period (Week 5 to Week 15)
Title
Percentage of Responder Subjects in Partial Onset Seizures (Type I) Over the Up-titration Period
Description
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.
Time Frame
During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Title
Categorized Percentage Response to Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
Description
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%.
Time Frame
During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
Title
Percent Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period
Description
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).
Time Frame
During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
UCB (+1 844 599 2273)
Official's Role
Study Director
Facility Information:
City
Phoenix
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Arizona
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United States
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Little Rock
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Arkansas
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United States
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Saint Petersburg
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Florida
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Springfield
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Illinois
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Wichita
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Kansas
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Detroit
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Michigan
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Chesterfield
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Missouri
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Cincinnati
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Ohio
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United States
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Columbus
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Ohio
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Philadelphia
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Pennsylvania
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Nashville
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Tennessee
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Dallas
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Texas
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Charlottesville
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Virginia
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Milwaukee
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Wisconsin
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United States
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Edmonton
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Alberta
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Canada
City
Calgary
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Canada
City
Montreal
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
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