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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003702-26 | EudraCT Number |
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| Name | Class |
|---|---|
| Eisai Limited | INDUSTRY |
This is a randomized, double-blind, placebo-controlled, parallel group study to determine the maximum tolerated dose of E2007. Epilepsy patients with refractory partial seizures will be divided into two groups of 24 patients each. One group will be patients who take concomitant inducing AEDs (anti-epileptic drugs) and the second group will be patients who do not take concomitant inducing AEDs. In each group, 18 patients will receive E2007 (dose escalating to a maximum of 12 mg per day) and six will receive placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2007 | Experimental | 2 mg E2007 once daily for 2 weeks (Days 1 to 14), then 4 mg E2007 once daily for 2 weeks (Days 15 to 28), then 6 mg E2007 once daily for 2 weeks (Days 29 to 42), then 8 mg E2007 once daily for 2 weeks (Days 43 to 56), then 10 mg E2007 once daily for 2 weeks (Days 57 to 70), then 12 mg E2007 once daily for 6 weeks (Days 71 to 112). |
|
| Placebo | Placebo Comparator | Matching placebo once daily for 16 weeks (Days 1 to 112) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2007 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders During the Maintenance Phase | A patient is a responder if she/he experiences a 50% or greater reduction in seizure frequency from the baseline phase. | Day 85 through Day 112 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in the 28-day Seizure Frequency From Baseline in the Maintenance LOCF | Baseline, Day 85 through Day 112 |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Julia Yang, MD, MBA | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P. Stradina Clinical University Hospital | Riga | LV-1002 | Latvia | |||
| Hospital Gailezers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37059702 | Derived | Bresnahan R, Hill RA, Wang J. Perampanel add-on for drug-resistant focal epilepsy. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD010961. doi: 10.1002/14651858.CD010961.pub2. | |
| 35305920 | Derived | Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo once daily for 16 weeks (Days 1 to 112) |
| FG001 | Perampanel | 2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112]) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo once daily for 16 weeks (Days 1 to 112) |
| BG001 | Perampanel | 2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112]) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Responders During the Maintenance Phase | A patient is a responder if she/he experiences a 50% or greater reduction in seizure frequency from the baseline phase. | ITT population- all subjects in the Safety Population (all randomized subjects who took at least 1 dose of study drug) who had at least 2 weeks of baseline seizure frequency data and at least 1 week of seizure frequency data after baseline (LOCF - last observation carried forward) | Posted | Number | Percentage of Participants | Day 85 through Day 112 |
|
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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 | Placebo | Matching placebo once daily for 16 weeks (Days 1 to 112) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colonic polyp | Gastrointestinal disorders | MedDRA V. 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA V. 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 888-422-4743 |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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|
| Riga |
| LV-1038 |
| Latvia |
| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race | Number | participants |
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|
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| Secondary | Percentage Change in the 28-day Seizure Frequency From Baseline in the Maintenance LOCF | ITT population (LOCF) | Posted | Median | Full Range | Percent change | Baseline, Day 85 through Day 112 |
|
|
|
| 1 |
| 10 |
| 7 |
| 10 |
| EG001 | Perampanel | 2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112]) | 1 | 38 | 15 | 38 |
| Convulsions | Nervous system disorders | MedDRA V. 10.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA V. 10.0 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA V. 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA V. 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA V. 10.0 | Systematic Assessment |
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| Muscle contractions involuntary | Nervous system disorders | MedDRA V. 10.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA V. 10.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA V. 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA V. 10.0 | Systematic Assessment |
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