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This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seletracetam | Experimental | Escalating doses twice daily were to be administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seletracetam (UCB44212) | Drug |
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| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | UCB (+1 844 599 2273) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
Participant Flow refers to the Intention-To-Treat Set. The study consisted of a 4-week Baseline Period, a 11-week Treatment Period (Up-/Down-Titration) and a 2-week Post-Treatment Period. Patients were up-titrated every two weeks until the maximum tolerated dose was reached. They were maintained at this dose until the end of the 8-week Up-Titration Period and continue that dose until the Down-Titration Visit scheduled for that dose level. Patients were to be down-titrated over a 3-week Period.
The study started to enroll patients in August 2005 and concluded in May 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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) |
| Little Rock |
| Arkansas |
| United States |
| St. Petersburg | Florida | United States |
| Springfield | Illinois | United States |
| Wichita | Kansas | United States |
| Detroit | Michigan | United States |
| Chesterfield | Missouri | United States |
| Cincinnati | Ohio | United States |
| Columbus | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Charlottesville | Virginia | United States |
| Milwaukee | Wisconsin | United States |
| Edmonton | Alberta | Canada |
| Calgary | Canada |
| Montreal | Canada |
| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristics refer to the Intention-to-Treat (ITT) population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period. | Posted | Median | Inter-Quartile Range | percentage of change | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4) |
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| Secondary | 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. | 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period. | Posted | Median | Inter-Quartile Range | percentage of change | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4) |
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| Secondary | 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. | 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period. | Posted | Median | Inter-Quartile Range | seizures per week | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4) |
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| Secondary | 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. | 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period. | Posted | Median | Inter-Quartile Range | seizures per week | During the Treatment Period (Week 5 to Week 15), compared to Baseline Period (Week 1 to Week 4) |
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| Secondary | 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. | 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period. | Posted | Median | Inter-Quartile Range | seizure frequency per week | During the Treatment Period (Week 5 to Week 15) |
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| Secondary | 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. | 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available data for the respective visit/ period are included in the analysis. Number of subjects analyzed is given separately for each visit/ period. | Posted | Median | Inter-Quartile Range | seizure frequency per week | During the Treatment Period (Week 5 to Week 15) |
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| Secondary | 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. | 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available post-baseline seizure data are included in the analysis. | Posted | Number | percentage of participants | During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4) |
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| Secondary | 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%. | 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available post-baseline seizure data are included in the analysis. | Posted | Number | percentage of participants | During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4) |
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| Secondary | 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). | 59 subjects were included in the ITT-set, who took at least one dose of trial medication. Only subjects with available post-baseline seizure data are included in the analysis. | Posted | Median | Inter-Quartile Range | percentage of change | During the Up-Titration Period (Week 5 to Week 12), compared to Baseline Period (Week 1 to Week 4) |
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Adverse events were collected from Baseline to Follow-Up visit (up to Week 17).
Adverse Events refer to the Intention-To-Treat (ITT) population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Seletracetam | Escalating doses of 10, 20, 40 and 80 mg b.i.d. (twice daily) (total daily doses of 20 - 160 mg) were to be administered orally as capsules. | 0 | 59 | 2 | 59 | 44 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
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| Irritability | General disorders | MedDRA | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Nystagmus | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C518915 | Seletracetam |
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| Visit 6 (Week 9 and 10) |
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| Visit 7 (Week 11 and 12) |
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| Up-titration (Weeks 5 to 12) |
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| Visit 8 (Week 13) |
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| Visit 9 (Week 14) |
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| Visit 10 (Week 15) |
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| Down-titration (Weeks 13 to 15) |
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| On Treatment (Weeks 5 to 15) |
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