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To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in participants with epilepsy. This study will be continued until perampanel is commercially available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perampanel | Experimental | Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel | Drug | Perampanel 2 mg tablets. Doses of perampanel can be adjusted based on clinical judgment. A minimum perampanel dose of 2 mg per day is required to continue in the study. The maximum daily dose of perampanel permitted will be 12 mg per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Safety was assessed by monitoring adverse events (AEs), withdrawal from treatment, clinical laboratory tests (chemistry), vital signs, and weight. TEAEs were defined as AEs that emerged from the first dose of study drug to the last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever comes later, having been absent at pretreatment (Baseline of Study 332). A markedly abnormal clinical chemistry laboratory value was defined as a laboratory result that worsened in severity to meet modified National Cancer Institute (NCI) toxicity criteria of Grade 2 or higher on treatment. Treatment-related TEAEs were defined as AEs that were considered by the investigator to be possibly or probably related to study treatment. SAEs were defined as any untoward medical occurrence that at any dose; resulted in death, disability/incapacity, birth defect, required inpatient hospitalization or prolongation of existing hospitalization, or was life-threatening. | From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matsuyama | Ehime | Japan | ||||
This study was conducted at 8 centers in Japan during the period of 12 May 2015 to 21 Sep 2016. E2007-J000-341 is an open-label extension of E2007-G000-332.
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| ID | Title | Description |
|---|---|---|
| FG000 | Perampanel | Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sapporo |
| Hokkaido |
| Japan |
| Inashiki-gun | Ibaraki | Japan |
| Uji | Kyoto | Japan |
| Sakai | Osaka | Japan |
| Matsue | Shimane | Japan |
| Nerima-Ku | Tokyo | Japan |
| Niigata | Japan |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included all participants who signed informed consent and received at least one dose of study drug, and had at least one post-dose safety assessment in Study 341.
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| ID | Title | Description |
|---|---|---|
| BG000 | Perampanel | Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day. |
| 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| 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 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel | Safety was assessed by monitoring adverse events (AEs), withdrawal from treatment, clinical laboratory tests (chemistry), vital signs, and weight. TEAEs were defined as AEs that emerged from the first dose of study drug to the last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever comes later, having been absent at pretreatment (Baseline of Study 332). A markedly abnormal clinical chemistry laboratory value was defined as a laboratory result that worsened in severity to meet modified National Cancer Institute (NCI) toxicity criteria of Grade 2 or higher on treatment. Treatment-related TEAEs were defined as AEs that were considered by the investigator to be possibly or probably related to study treatment. SAEs were defined as any untoward medical occurrence that at any dose; resulted in death, disability/incapacity, birth defect, required inpatient hospitalization or prolongation of existing hospitalization, or was life-threatening. | Safety analysis set included all participants who signed informed consent and received at least one dose of study drug, and had at least one post-dose safety assessment in Study 341. | Posted | Number | Participants | From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months |
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From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months
Treatment-emergent adverse events (TEAEs) and serious adverse events were reported. The safety analysis set included all participants who signed informed consent and received at least one dose of study drug, and had at least one post-dose safety assessment in Study 341. TEAEs were AEs that emerged from first dose of study drug to last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever came later, having been absent at Baseline of the Study 332.
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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 | Perampanel | Participants started the study with the dose that they were receiving at the end of their participation in the previously participated Study E2007-G000-332 (Study 332) [NCT02307578]. Doses of perampanel were allowed to be adjusted based on clinical judgment. A minimum perampanel dose of 2 milligram (mg) per day was required to continue in the study. The maximum daily dose of perampanel permitted was 12 mg per day. | 0 | 7 | 0 | 7 | 6 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 19.0. | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 19.0. | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 19.0. | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 19.0. | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 19.0. | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.0. | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 19.0. | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 19.0. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hidetaka Hiramatsu | Eisai Co., Ltd. | +81-3-3817-5245 | esi_medinfo@eisai.com |
| 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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| Title | Measurements |
|---|---|
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| TEAEs leading to study drug dose adjustment |
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| Serious TEAE |
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