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The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.
This is a global, observational, cohort study in patients with epilepsy. Multiple treating physicians will prescribe perampanel to approximately 500 patients, who then will be observed for approximately 52 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perampanel | Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel | Drug | Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) of interest | Assessment of events of dizziness, blurred vision, somnolence, aggression, balance disorders, ataxia, falls, unintended pregnancy, weight gain, suicidality, drug abuse, misuse, dependence, withdrawal, off-label use, skin photosensitivity, unintended pregnancy while taking levonorgestrel-containing contraceptives, and outcomes associated with any suspected drug-drug interaction. | Up to 52 weeks and 2 weeks of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of unintended pregnancy | Up to 52 weeks | |
| Incidence of off-label use | Up to 52 weeks | |
| Summary scores for the Hospital Anxiety and Depression Scale (HADS) |
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Inclusion Criteria
Exclusion Criteria
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Epilepsy patients prescribed adjunctive treatment in countries where perampanel has received marketing approval. Multiple treating physicians will prescribe perampanel to patients, who then will be observed for approximately 52 weeks.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitatsklinikum Innsbruck | Innsbruck | 6020 | Austria | |||
| Kepler Universitätsklinikum |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35305920 | Derived | Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available. | |
| 34953337 | Derived | Maguire M, Ben-Menachem E, Patten A, Malhotra M, Ngo LY. A post-approval observational study to evaluate the safety and tolerability of perampanel as an add-on therapy in adolescent, adult, and elderly patients with epilepsy. Epilepsy Behav. 2022 Jan;126:108483. doi: 10.1016/j.yebeh.2021.108483. Epub 2021 Dec 23. |
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| Screening, Week 52 |
| Number of TEAEs in the patient subpopulations of interest | TEAEs observed in the specified subpopulations of patients could also be made in order to get a better understanding of whether any of these particular potential risk factors (e.g., old age, cardiovascular disease) define groups with greater or lesser risk. | Up to 52 weeks and 2 weeks of follow-up |
| Clinical Global Impression of Change | Assessment of disease severity will utilize the Clinical Global Impression of Change (CGI-C) scale at end of treatment to evaluate change in disease status since initiation of treatment. | Week 52 |
| Linz |
| 4020 |
| Austria |
| Krankenhaus Wien-Hietzing | Vienna | 1130 | Austria |
| Eisai Site# 2405 | Battice | Belgium |
| Hôpital Erasme | Brussels | 1070 | Belgium |
| Eisai Site# 2404 | Brussels | Belgium |
| Eisai Site# 2406 | Duffel | Belgium |
| Uz Leuven | Leuven | 3000 | Belgium |
| Eisai Site# 2409 | Liège | Belgium |
| Eisai Site# 2403 | Ottignies | Belgium |
| Eisai Site# 2408 | Ruddershove | Belgium |
| Eisai Site# 2407 | Woluwe-Saint-Lambert | Belgium |
| Eisai Site# 2402 | Yvoir | Belgium |
| Eisai Site# 2601 | Beroun | Czechia |
| Eisai Site# 2600 | Brno | Czechia |
| Eisai Site# 2606 | Hradec Králové | Czechia |
| Eisai Site# 2602 | Náchod | Czechia |
| Cerebrovaskularni Poradna S.R.O. | Ostrava | 72200 | Czechia |
| Eisai Site# 2603 | Prague | Czechia |
| Eisai Site# 2013 | Beersheba | Israel |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Edith Wolfson Medical Center | Holon | 58100 | Israel |
| Kiryat Hadassah | Jerusalem | Israel |
| Meir Medical Center | Kfar Saba | 4428164 | Israel |
| Western Galilee Hospital | Nahariya | 22100 | Israel |
| Schneider Children's Medical Center Of Israel | Petah Tikva | 49202 | Israel |
| The Chaim Sheba Medical Center | Ramat Gan | Israel |
| Tel-Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Eisai Site# 2003 | Tel Aviv | Israel |
| Eisai Site# 2012 | Tel Aviv | Israel |
| Eisai Site# 2008 | Tel Litwinsky | Israel |
| Sahlgrenska Universitetssjukhuset | Gothenburg | SE-41345 | Sweden |
| Universitetssjukhuset I Linköping | Linköping | 58185 | Sweden |
| Eisai Site# 1607 | Bristol | United Kingdom |
| Ninewells Hospital | Dundee | Dd1 9Sy | United Kingdom |
| Eisai Site# 1611 | Lincoln | United Kingdom |
| Eisai Site# 1604 | London | United Kingdom |
| Eisai Site# 1608 | London | United Kingdom |
| Eisai Site# 1609 | London | United Kingdom |
| Great Ormond Street hospital | London | United Kingdom |
| Eisai Site# 1612 | Newcastle | United Kingdom |
| Eisai Site# 1606 | Truro | United Kingdom |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C551441 | perampanel |
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