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The primary purpose of this study is to investigate the effectiveness reflected by the retention rate of perampanel as the only add-on treatment in adult participants with primary generalized tonic-clonic (PGTC) or secondarily generalized tonic-clonic (SGTC) seizures based on focal or idiopathic generalized epilepsy in a non-interventional (observational) setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perampanel | Participants with PGTC or SGTC seizures may receive perampanel tablets or oral suspension as only add-on therapy based on physicians decision in accordance with summary of product characteristics (SmPC) and will be observed at baseline, 6 months (intermediate visit), and 12 months (final visit). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel | Drug | Perampanel tablets. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Remaining on Perampanel at Month 12 (Retention Rate) | The retention rate is defined as the percentage of participants remaining on perampanel treatment at 12 months after the initiation of treatment. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Remaining on Perampanel at Month 6 (Retention Rate) | The retention rate is defined as the percentage of participants remaining on perampanel treatment at 6 months after the initiation of treatment. | Month 6 |
| Percentage of Participants Who Achieved Seizure Freedom for All Generalized Tonic-clonic (GTC) Seizures at Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with PGTC or SGTC seizures.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Trial Site #51 | Aalen | Germany | ||||
| Eisai Trial Site #12 |
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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| Perampanel | Drug | Perampanel oral suspension. |
|
|
| Month 12 |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Treatment-emergent Serious Adverse Events (SAE), and Adverse Events (AEs) by Severity | AEs will be graded on a 3-point scale that is mild (discomfort noticed, but no disruption of normal daily activity), moderate (discomfort sufficient to reduce or affect normal daily activity), and severe (incapacitating, with inability to work or to perform normal daily activity). | Up to Month 12 |
| Berlin |
| Germany |
| Eisai Trial Site #43 | Berlin | Germany |
| Eisai Trial Site #15 | Bernau | Germany |
| Eisai Trial Site #8 | Bielefeld | Germany |
| Eisai Trial Site #53 | Bochum | Germany |
| Eisai Trial Site #38 | Bonn | Germany |
| Eisai Trial Site #9 | Bonn | Germany |
| Eisai Trial Site #25 | Damp | Germany |
| Eisai Trial Site #48 | Dortmund | Germany |
| Eisai Trial Site #27 | Dresden | Germany |
| Eisai Trial Site #50 | Dresden | Germany |
| Eisai Trial Site #7 | Erlangen | Germany |
| Eisai Trial Site #44 | Friedrichshafen | Germany |
| Eisai Trial Site #4 | Greifswald | Germany |
| Eisai Trial Site #21 | Hamburg | Germany |
| Eisai Trial Site #47 | Hamburg | Germany |
| Eisai Trial Site #14 | Jena | Germany |
| Eisai Trial Site #18 | Kiel | Germany |
| Eisai Trial Site #54 | Kiel | Germany |
| Eisai Trial Site #1 | Kork | Germany |
| Eisai Trial Site #24 | Leipzig | Germany |
| Eisai Trial Site #28 | Lübeck | Germany |
| Eisai Trial Site #26 | Magdeburg | Germany |
| Eisai Trial Site #13 | Mainz | Germany |
| Eisai Trial Site #36 | Mittweida | Germany |
| Eisai Trial Site #42 | Nierstein | Germany |
| Eisai Trial Site #2 | Radeberg | Germany |
| Eisai Trial Site #16 | Ravensburg | Germany |
| Eisai Trial Site #23 | Regensburg | Germany |
| Eisai Trial Site #46 | Remscheid | Germany |
| Eisai Trial Site #3 | Tübingen | Germany |
| Eisai Trial Site #37 | Ulm | Germany |
| Eisai Trial Site #40 | Weil der Stadt | Germany |
| 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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