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The purpose of the study is to evaluate the safety and efficacy of Fycompa® (perampanel) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy aged 12 years and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fycompa® (perampanel) | Fycompa® (perampanel) (oral tablets) treatment will be initiated at 2 milligram (mg) once daily according to the approved package insert, as an add-on drug in addition to other anti-epileptic drugs (AEDs) as prescribed by physician. The dose will be increased based on clinical response and tolerability (by increments of 2 mg/day to a maintenance dose of 4 to 12 mg/day) and participants will be enrolled and observed prospectively for up to 54 Weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel | Drug | Perampanel tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | AESI will include medication errors, lack of therapeutic efficacy, overdose, abuse, misuse, occupational exposure, paternal exposure and off label use, pregnancy, and exposure to drug during breast feeding. | Up to 54 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 28-day Seizure Count at the End of Treatment Period (Week 52) | Baseline, Week 52 | |
| Response Rate | Response rate will be defined as number of participants with response defined as more than or equal to (>=) 50 percent (%) reduction in 28-day seizure frequency from Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with epilepsy aged 12 years or older.
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 |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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| Baseline, Week 12, Week 24 and Week 52 |
| Change From Baseline in Clinical Global Impression of Change (CGIC) Scores | The CGIC is an assessment performed by the clinician, evaluating the change in the participant's symptoms over time. Assessment will be implemented based on frequency of seizure, severity of seizures, adverse events, and overall conditions on a 7-point scale with the scores as 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse. | Baseline, Week 12, Week 24 and Week 52 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |