- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00152451
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
An Open-label, Exploratory, Multicenter, Dose-escalation Study Examining the Efficacy, Safety and Tolerability of Ucb 44212 Used at Doses of 10 mg, 20 mg, 40 mg and 80 mg b.i.d. (Total Daily Dose of 20 to 160 mg) in Adult Subjects (18-65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures (Whether or Not Secondarily Generalized) and Treated With 1, 2 or 3 Approved Antiepileptic Drugs
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- N01191 108
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California
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San Francisco, California, United States, 94115
- N01191 105
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Stanford, California, United States, 94305
- N01191 102
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Ohio
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Columbus, Ohio, United States, 43210
- N01191 107
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- N01191 104
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Tennessee
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Nashville, Tennessee, United States, 37212
- N01191 101
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Virginia
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Charlottesville, Virginia, United States, 22903
- N01191 103
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Seletracetam
Escalating doses twice daily were to be administered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) During 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)
|
Calculated as (7-day seizure frequency during the up-titration 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 duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12). |
During the Up-titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change From Baseline in Seizure Frequency Per Week of Partial Onset Seizures (Type I) by Visit Over the Treatment Period (Up-titration + Down-titration)
Time Frame: 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. |
During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
|
Percentage Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period
Time Frame: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
|
Calculated as (7-day seizure frequency during the down-titration 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 duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15). |
During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
|
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) by Visit Over the Treatment Period (Up-titration + Down-titration)
Time Frame: 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. |
During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4)
|
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in 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)
|
Calculated as (7-day seizure frequency during the up-titration 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 duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12). |
During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4)
|
Percentage Change From Baseline in Seizure Frequency Per Week for All Seizure Types (Types I+II+III) Overall in the Down-titration Period
Time Frame: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
|
Calculated as (7-day seizure frequency during the down-titration 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 duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15). |
During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
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Seizure Frequency Per Week for Partial Onset Seizures (Type I) by Visit Over the Treatment Period
Time Frame: 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.
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During the Treatment Period (Week 5 to Week 15)
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Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Treatment Period
Time Frame: 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).
|
During the Treatment Period (Week 5 to Week 15)
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Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Up-titration Period
Time Frame: During the Up-Titration Period (Week 5 to Week 12)
|
Calculated as 7-day partial onset seizure (type I) frequency.
The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
|
During the Up-Titration Period (Week 5 to Week 12)
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Seizure Frequency Per Week for Partial Onset Seizure (Type I) Overall in the Down-titration Period
Time Frame: During the Down-Titration Period (Week 13 to Week 15)
|
Calculated as 7-day partial onset seizure (type I) frequency.
The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
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During the Down-Titration Period (Week 13 to Week 15)
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Seizure Frequency Per Week for All Seizure Types (Type I+II+III) by Visit Over the Treatment Period
Time Frame: 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.
|
During the Treatment Period (Week 5 to Week 15)
|
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Treatment Period
Time Frame: 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).
|
During the Treatment Period (Week 5 to Week 15)
|
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Up-titration Period
Time Frame: During the Up-Titration Period (Week 5 to Week 12)
|
Calculated as 7-day seizure frequency for all seizure types (type I+II+III).
The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
|
During the Up-Titration Period (Week 5 to Week 12)
|
Seizure Frequency Per Week for All Seizure Types (Type I+II+III) Overall in the Down-titration Period
Time Frame: During the Down-Titration Period (Week 13 to Week 15)
|
Calculated as 7-day seizure frequency for all seizure types (type I+II+III).
The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
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During the Down-Titration Period (Week 13 to Week 15)
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Responder Rate in Partial Onset Seizures (Type I) Over the Up-titration Period
Time Frame: Week 12, compared to Baseline Period (Week 1 to Week 4)
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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.
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Week 12, compared to Baseline Period (Week 1 to Week 4)
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Percentage of Participants With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Up-titration Period
Time Frame: Week 12, compared to Baseline Period (Week 1 to Week 4)
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Categories of percentage change in seizures from Baseline were as following: < -25%; -25% to <25%; 25% to <75%; 75% to <100%; 100%.
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Week 12, compared to Baseline Period (Week 1 to Week 4)
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Percentage Change From Baseline in Seizure-free Days Per Week Over the Up-titration Period
Time Frame: Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)
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A day was considered seizure-free, if no seizure was reported during 24 hours.
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Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)
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Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Overall in the Down-titration Period
Time Frame: During the Down-Titration Period (Week 13 to Week 15), compared to Baseline Period (Week 1 to Week 4)
|
Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)).
A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline.
The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
|
During the Down-Titration Period (Week 13 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) During the Up-titration Period
Time Frame: Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)
|
Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)).
A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline.
The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
|
Week 5 to Week 12, 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) Overall in the Down-titration Period
Time Frame: Week 13 to Week 15, compared to Baseline Period (Week 1 to Week 4)
|
Calculated as (7-day seizure frequency during the down-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)).
A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline.
The duration of the Down-Titration Period was 3 weeks (Visit 7/Week 13 to Visit 10/Week 15).
|
Week 13 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) Overall in the Up-titration Period
Time Frame: Week 5 to Week 12, compared to Baseline Period (Week 1 to Week 4)
|
Calculated as (7-day seizure frequency during the up-titration period) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)).
A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline.
The duration of the Up-Titration Period was 8 weeks (Visit 3/Week 5 to Visit 7/Week 12).
|
Week 5 to Week 12, 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 Over the Treatment Period (Up-titration + Down-titration)
Time Frame: Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4)
|
Calculated as (7-day seizure frequency during the treatment period for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)).
The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n.
A negative value in change from Baseline indicates a decrease in partial onset seizure frequency from Baseline.
The Overall 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).
|
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 Over the Treatment Period (Up-titration + Down-titration)
Time Frame: Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4)
|
Calculated as (7-day seizure frequency during the treatment period for visit n) - (7-day seizure frequency during the Baseline Period (Week 1 to Week 4)).
The treatment period referred to includes the period from the previous visit n-1 up to but not including the specific visit n.
A negative value in change from Baseline indicates a decrease in all seizure types frequency from Baseline.
The Overall 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).
|
Week 5 to Week 15, compared to Baseline Period (Week 1 to Week 4)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: UCB Cares, UCB (+1 844 599 2273)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N01191
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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