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The purpose of this study is to determine the safety of Fycompa for injection after administration in participants with epilepsy (partial-onset seizures [including secondarily generalized seizures]) (age 4 years or older) or primary generalized tonic-clonic seizures (age 12 years or older).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fycompa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is a non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Drug Reactions (ADRs) and Adverse Events (AEs) | Up to 4 weeks | |
| Number of Participants With ADRs Based on Participant Characteristic | Up to 4 weeks | |
| Plasma Concentration of Fycompa in Children Aged Greater Than or Equal to (>=) 4 Years and Less than (<) 12 Years | Up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with epilepsy who received the Fycompa for injection for the first time will be included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inquiry Service | Contact | 0120-419-497 | eisai-chiken_hotline@hhc.eisai.co.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1 | Recruiting | Tokyo | Japan |
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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| 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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