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The objective of this study is to identify the following in adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fycompa-treated epilepsy participants | Adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fycompa | Drug | The usual oral dosage for adults and children 12 years of age or older is initially 2 milligrams (mg) once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 1 week or longer. The maintenance dose is 8 mg once daily in the absence of concomitant antiepileptic drugs that accelerate the metabolism of this product, or 8 to 12 mg once daily in the presence of such concomitant drugs. The dosage may be increased or decreased as necessary by 2 mg at intervals of 1 week or longer depending on symptoms, but the maximum daily dose should not be over 12 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with any serious adverse event | from 0 to 52 weeks | |
| Number of participants with any non-serious adverse event | from 0 to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing seizures | from 0 to 52 weeks | |
| Overall improvement rating in seizure frequency | from 0 to 52 weeks |
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Inclusion Criteria:
Epilepsy participants at least 18 years of age with:
Exclusion Criteria:
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Participants with epilepsy who will receive Fycompa per the approved indication in routine clinical practice
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| Name | Affiliation | Role |
|---|---|---|
| Kenta Sumitomo | Drug Fostering and Evolution Coordination Department. Medical Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34782307 | Result | Inoue Y, Sumitomo K, Matsutani K, Ishii M. Evaluation of real-world effectiveness of perampanel in Japanese adults and older adults with epilepsy. Epileptic Disord. 2022 Feb 1;24(1):123-132. doi: 10.1684/epd.2021.1369. |
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|
| Tokyo |
| Japan |
| ID | Term |
|---|---|
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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