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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006169-33 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
| |
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perampanel | Drug | 2 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) | Seizure frequency per 28 days was derived from the information recorded in the subject diaries. | Baseline (Pre-randomization) through Week 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate | The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre-randomization phase. | Baseline (Pre-randomization) through Week 19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Squillacote, M.D. | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Queen Elizabeth Hospital | Woodville | South Australia | 5011 | Australia | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37059702 | Derived | Bresnahan R, Hill RA, Wang J. Perampanel add-on for drug-resistant focal epilepsy. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD010961. doi: 10.1002/14651858.CD010961.pub2. | |
| 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase) |
| FG001 | Perampanel 2mg | Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| perampanel | Drug | 4 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose. |
|
|
| perampanel | Drug | 8 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose. |
|
|
| Placebo | Drug | Placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily. |
|
| Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) |
Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries. |
| Baseline (Pre-randomization) through Week 19 |
| Woodville South |
| South Australia |
| 5011 |
| Australia |
| Clayton | Victoria | 3168 | Australia |
| Fitzroy | Victoria | 3065 | Australia |
| Heidelberg | Victoria | 3081 | Australia |
| Parkville | Victoria | 3050 | Australia |
| Clayton | 3168 | Australia |
| Fitzroy | 3065 | Australia |
| Parkville | 3050 | Australia |
| West Heidelberg | 3081 | Australia |
| Woodville | 5011 | Australia |
| Pleven | 5800 | Bulgaria |
| Plovdiv | 4002 | Bulgaria |
| Sofia | 1113 | Bulgaria |
| Sofia | 1606 | Bulgaria |
| Brno | 625 00 | Czechia |
| Olomouc | 775 20 | Czechia |
| Prague | 140 59 | Czechia |
| Prague | 150 06 | Czechia |
| Tallinn | EE-10617 | Estonia |
| Tallinn | EE-13419 | Estonia |
| Tartu | EE-51014 | Estonia |
| Düsseldorf | 40212 | Germany |
| Kehl-Kork | 77694 | Germany |
| Konigstein-Falkenstein | D-61462 | Germany |
| Mainz | 55101 | Germany |
| Marburg | 35039 | Germany |
| München | 80333 | Germany |
| München | 81377 | Germany |
| Ulm | 89075 | Germany |
| Westerstede | 26655 | Germany |
| Queen Mary Hospital | Hong Kong | 999077 | Hong Kong |
| Hong Kong | Hong Kong |
| Queen Elizabeth Hospital | Kowloon | Hong Kong |
| United Christian Hospital | Kowloon | Hong Kong |
| Kowloon | Hong Kong |
| Prince of Wales Hospital | Shatin | Hong Kong |
| Budapest | 1083 | Hungary |
| Budapest | 1096 | Hungary |
| Budapest | 1145 | Hungary |
| Budapest | 1146 | Hungary |
| Kecskemét | 6000 | Hungary |
| Hyderabad | Andhra Pradesh | 500001 | India |
| Hyderabad | Andhra Pradesh | 500082 | India |
| Visakhapatnam | Andhra Pradesh | 530002 | India |
| Mumbai | Maharashtra | 400026 | India |
| Pune | Maharashtra | 411011 | India |
| Pune | Maharashtra | 411030 | India |
| Jaipur | Rajasthan | 302004 | India |
| New Delhi | 110002 | India |
| Milan | 20133 | Italy |
| Naples | 80128 | Italy |
| Padova | 35128 | Italy |
| Siena | 53100 | Italy |
| Torino | 10126 | Italy |
| Riga | LV-1004 | Latvia |
| Riga | LV-1038 | Latvia |
| Valmiera | LV-4201 | Latvia |
| Kaunas | LT-50009 | Lithuania |
| KlaipÄ—da | LT-92288 | Lithuania |
| Vilnius | LT-08661 | Lithuania |
| Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
| Kuala Terengganu | Terengganu | 24000 | Malaysia |
| Ermita | 1000 | Philippines |
| Makati City | 1229 | Philippines |
| Bialystok | 15-276 | Poland |
| Gdansk | 80-803 | Poland |
| Gdansk | 80-952 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach | Katowice | 40-635 | Poland |
| Katowice | 40-635 | Poland |
| Lodz | 93-513 | Poland |
| Lublin | 20-718 | Poland |
| Warsaw | 02-957 | Poland |
| Coimbra | 3000-075 | Portugal |
| Lisbon | 1649-035 | Portugal |
| Porto | 4099-001 | Portugal |
| Porto | 4200-319 | Portugal |
| Brasov | 500061 | Romania |
| Sapiens Medical Center | Bucharest | 011635 | Romania |
| Bucharest | 011635 | Romania |
| Colentina Clinical Hospital | Bucharest | 020125 | Romania |
| Bucharest | 20125 | Romania |
| Emergency County Clinical Hospital | Cluj-Napoca | 400012 | Romania |
| Pediatric Neurology Clinic of Emergency Children Hospital | Cluj-Napoca | 400012 | Romania |
| Cluj-Napoca | 400012 | Romania |
| Moscow State University of Medicine and Dentistry | Moscow | 107066 | Russia |
| Moscow | 107066 | Russia |
| Moscow Research Institute of Psychiatry | Moscow | 107076 | Russia |
| Moscow | 107076 | Russia |
| Moscow Research Institute of Pediatrics and Pediatric Surgery | Moscow | 125412 | Russia |
| Moscow | 125412 | Russia |
| Samara | 443095 | Russia |
| Tyumen | 625039 | Russia |
| Yaroslavl | 150030 | Russia |
| Yekaterinburg | 620149 | Russia |
| Belgrade | 11000 | Serbia |
| Niš | 18000 | Serbia |
| Novi Sad | 21000 | Serbia |
| Busan | 602715 | South Korea |
| Busan | 614735 | South Korea |
| Daegu | 700712 | South Korea |
| Seoul | 110744 | South Korea |
| Seoul | 120752 | South Korea |
| Seoul | 135710 | South Korea |
| Seoul | 138736 | South Korea |
| Granada | Andalusia | 18012 | Spain |
| Badalona | Catalonia | 8916 | Spain |
| Barcelona | Catalonia | 8003 | Spain |
| Barcelona | Catalonia | 8025 | Spain |
| Alcorcón | Madrid | 28922 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Valencia | Valencia | 46009 | Spain |
| Valencia | Valencia | 46014 | Spain |
| Barcelona | 08003 | Spain |
| Valencia | 46009 | Spain |
| Kaohsiung City | 833 | Taiwan |
| Taichung | 404 | Taiwan |
| Taichung | 40705 | Taiwan |
| Tainan | 704 | Taiwan |
| Taoyuan | 333 | Taiwan |
| Bangkok | 10330 | Thailand |
| Bangkok | 10400 | Thailand |
| Bangkok | 10700 | Thailand |
| Chiang Mai | 50200 | Thailand |
| Khon Kaen | 40004 | Thailand |
| Muang District | 34000 | Thailand |
| Dnipropetrovsk | 40927 | Ukraine |
| Dnipropetrovsk | 49027 | Ukraine |
| Donetsk | 83052 | Ukraine |
| Donetsk | 83114 | Ukraine |
| Kharkiv | 61018 | Ukraine |
| Kharkiv | 61068 | Ukraine |
| Kyiv | 040209 | Ukraine |
| Kyiv | 04080 | Ukraine |
| Kyiv | 04209 | Ukraine |
| Lviv | 79010 | Ukraine |
| Uzhhorod | 88018 | Ukraine |
| 25878175 | Derived | French JA, Gil-Nagel A, Malerba S, Kramer L, Kumar D, Bagiella E. Time to prerandomization monthly seizure count in perampanel trials: A novel epilepsy endpoint. Neurology. 2015 May 19;84(20):2014-20. doi: 10.1212/WNL.0000000000001585. Epub 2015 Apr 15. |
| 25823975 | Derived | Rosenfeld W, Conry J, Lagae L, Rozentals G, Yang H, Fain R, Williams B, Kumar D, Zhu J, Laurenza A. Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase III randomized clinical studies and a combined extension study. Eur J Paediatr Neurol. 2015 Jul;19(4):435-45. doi: 10.1016/j.ejpn.2015.02.008. Epub 2015 Mar 5. |
| 23663001 | Derived | Steinhoff BJ, Ben-Menachem E, Ryvlin P, Shorvon S, Kramer L, Satlin A, Squillacote D, Yang H, Zhu J, Laurenza A. Efficacy and safety of adjunctive perampanel for the treatment of refractory partial seizures: a pooled analysis of three phase III studies. Epilepsia. 2013 Aug;54(8):1481-9. doi: 10.1111/epi.12212. Epub 2013 May 10. |
| 22517103 | Derived | Krauss GL, Serratosa JM, Villanueva V, Endziniene M, Hong Z, French J, Yang H, Squillacote D, Edwards HB, Zhu J, Laurenza A. Randomized phase III study 306: adjunctive perampanel for refractory partial-onset seizures. Neurology. 2012 May 1;78(18):1408-15. doi: 10.1212/WNL.0b013e318254473a. Epub 2012 Apr 18. |
| FG002 | Perampanel 4mg | Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks) |
| FG003 | Perampanel 8 mg | Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase) |
| BG001 | Perampanel 2mg | Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase) |
| BG002 | Perampanel 4mg | Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks) |
| BG003 | Perampanel 8 mg | Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | The number of participants started is not consistant with the number of Baseline Participants due to 6 participants who were randomized in the study, but not treated with study drug. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Race | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) | Seizure frequency per 28 days was derived from the information recorded in the subject diaries. | Full Intent-to-Treat (ITT) Analysis Set - group of subjects who were randomized to study drug, received study drug, and had any seizure frequency data during the Double-blind Phase. | Posted | Median | Full Range | Percent Change | Baseline (Pre-randomization) through Week 19 |
|
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| Secondary | Responder Rate | The responder rate for the Full ITT Analysis Set from the maintenance LOCF (Last Observation Carried Forward). A responder was a subject who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre-randomization phase. | Full ITT Analysis Set. | Posted | Number | Percentage of Participants | Baseline (Pre-randomization) through Week 19 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) | Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries. | Full ITT Analysis Set | Posted | Median | Full Range | Percent Change | Baseline (Pre-randomization) through Week 19 |
|
From the time the subject signed the informed consent form to 30 days after the last dose of the study drug.
Adverse events were assessed at clinical visits based on the subject's diary, vitals, weight, physical examination, neurological exam, and laboratory evaluations; and by telephone interviews/contact.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase) | 9 | 185 | 48 | 185 | ||
| EG001 | Perampanel 2mg | Perampanel 2mg daily over 19-weeks (during 6-week Titration phase and 13-week Maintenance phase) | 6 | 180 | 61 | 180 | ||
| EG002 | Perampanel 4mg | Perampanel 4mg maximum daily dose (Titration from 2mg to 4mg daily over 6-weeks; Maintenance at 4 mg daily over 13-weeks) | 6 | 172 | 66 | 172 | ||
| EG003 | Perampanel 8 mg | Perampanel 8mg maximum daily dose (Titration from 2mg to 8mg daily over 6-weeks; Maintenance at 8 mg daily over 13-weeks) | 6 | 169 | 79 | 169 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Goitre | Endocrine disorders | MedDRA V. 13.0 |
| ||
| Conjunctivitis allergic | Eye disorders | MedDRA V. 13.0 |
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| Iritis | Eye disorders | MedDRA V. 13.0 |
| ||
| Cholelithiasis | Hepatobiliary disorders | MedDRA V. 13.0 |
| ||
| Appendicitis | Infections and infestations | MedDRA V. 13.0 |
| ||
| Wound infection | Infections and infestations | MedDRA V. 13.0 |
| ||
| Bronchitis | Infections and infestations | MedDRA V. 13.0 |
| ||
| Orchitis | Infections and infestations | MedDRA V. 13.0 |
| ||
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA V. 13.0 |
| ||
| Contusion | Injury, poisoning and procedural complications | MedDRA V. 13.0 |
| ||
| Head injury | Injury, poisoning and procedural complications | MedDRA V. 13.0 |
| ||
| Post concussion syndrome | Injury, poisoning and procedural complications | MedDRA V. 13.0 |
| ||
| Rib fracture | Injury, poisoning and procedural complications | MedDRA V. 13.0 |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA V. 13.0 |
| ||
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA V. 13.0 |
| ||
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA V. 13.0 |
| ||
| Bone erosion | Musculoskeletal and connective tissue disorders | MedDRA V. 13.0 |
| ||
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA V. 13.0 |
| ||
| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V. 13.0 |
| ||
| Convulsion | Nervous system disorders | MedDRA V. 13.0 |
| ||
| Dizziness | Nervous system disorders | MedDRA V. 13.0 |
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| Epilepsy | Nervous system disorders | MedDRA V. 13.0 |
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| Simple partial seizures | Nervous system disorders | MedDRA V. 13.0 |
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| Somnolence | Nervous system disorders | MedDRA V. 13.0 |
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| Tremor | Nervous system disorders | MedDRA V. 13.0 |
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| Grand mal convulsion | Nervous system disorders | MedDRA V. 13.0 |
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| Transient ischaemic attack | Nervous system disorders | MedDRA V. 13.0 |
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| Aggression | Psychiatric disorders | MedDRA V. 13.0 |
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| Confusional state | Psychiatric disorders | MedDRA V. 13.0 |
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| Delirium | Psychiatric disorders | MedDRA V. 13.0 |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA V. 13.0 |
| ||
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA V. 13.0 |
| ||
| Medical device removal | Surgical and medical procedures | MedDRA V. 13.0 |
| ||
| Aortic stenosis | Vascular disorders | MedDRA V. 13.0 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA V. 13.0 |
| ||
| Gait disturbance | General disorders | MedDRA V. 13.0 |
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| Nasopharyngitis | Infections and infestations | MedDRA V. 13.0 |
| ||
| Upper respiratory tract infection | Infections and infestations | MedDRA V. 13.0 |
| ||
| Dizziness | Nervous system disorders | MedDRA V. 13.0 |
| ||
| Headache | Nervous system disorders | MedDRA V. 13.0 |
| ||
| Somnolence | Nervous system disorders | MedDRA V. 13.0 |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 888-422-4743 |
| 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 |
Not provided
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| 18-64 Years |
|
| >64 Years |
|
| Male |
|
| Asian |
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| Chinese |
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| Other |
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