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The purpose of this study is to assess the safety of perampanel in the treatment of partial onset seizures in participants of age 12 years and older with epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perampanel | Participants receiving perampanel tablets, orally according to prescribing information and the treating physician's clinical judgment will be observed prospectively for up to 6 months or participant withdrawal, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel | Drug | Perampanel tablets. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Seizure Frequency per 28 days During the Treatment Period | Up to 6 months | |
| Percentage of Participants Who Experienced at Least 50 Percent Reduction From Baseline in Seizure Frequency During the Treatment Period | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Indian participants with epilepsy aged 12 years or older.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BGS Gleneagles Global Hospitals | Bengaluru | Karnataka | 560060 | India | ||
| Seth G S Medical College & KEM Hospital |
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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| Percentage of Participants Who Achieved a Seizure-free Status During the Treatment Period | At 3 months and 6 months |
| Mumbai |
| Maharashtra |
| 400012 |
| India |
| Brain Clinic, Jasleen Hospital | Nagpur | Maharashtra | 440012 | India |
| Getwell Hospital and Research Institute | Nagpur | Maharashtra | 440012 | India |
| Deenanath Mangeshkar Hospital and Research Centre | Pune | Maharashtra | 411004 | India |
| Lifepoint Multispecialty Hospital | Pune | Maharashtra | 411057 | India |
| Nizam's Institute of Medical Sciences Department of Neurology | Hyderabad | Telangana | 500082 | India |
| Sanjay Gandhi Post Graduate Institute of Medical Sciences | Lucknow | Uttar Pradesh | 226014 | India |
| Ramakrishna mission seva pratisthan vivekananda institute of medical sciences | Kolkata | West Bengal | 700026 | India |
| Sri Aurobindo Seva Kendra | Kolkata | West Bengal | 700068 | India |
| Shri Ganga Ram Hospital | Delhi | India |
| Advance Neurology & Superspeciality Hospital | Jaipur | India |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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