Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
NCT ID: NCT00735397
Last Updated: 2016-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1218 participants
INTERVENTIONAL
2008-10-31
2014-09-30
Brief Summary
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Evaluating the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
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To Evaluate The Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
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Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
NCT00700310
A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
NCT01618695
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Perampanel
Participants previously receiving perampanel/placebo in the double blind-study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years.
perampanel
Perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years
Interventions
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perampanel
Perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3. Who was considered reliable and willing to be available for the study period and record seizures and report adverse events them self or have a caregiver who can record and report the events for them.
4. Females who were either of non-childbearing potential (defined as having undergone surgical sterilization, or postmenopausal \[\>age 50 and amenorrheic for 12 months\]) or of childbearing potential. Females of childbearing potential were enrolled only if they agreed to be abstinent or continue using at least 1 medically acceptable method of contraception (eg, a double-barrier method \[eg, condom + spermicide, condom + diaphragm with spermicide\], IUD, or have a vasectomised partner) throughout the study period and for 2 months after the last dose of study drug. Women using hormonal contraceptives were required to use an additional approved method of contraception (as described previously) continuously throughout the entire study period and for 2 months after the last dose of study drug. (It was not required for male subjects to use contraceptive measures based on preclinical toxicology data).
5. Continued to be treated with a stable dose of 1 or a maximum of 3 approved anti-epileptic drugs.
Participants who met the following criteria were excluded from the study:
1\. Those who, for any reason, discontinued early from the preceding double-blind study.
12 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michelle Gee, PhD.
Role: STUDY_DIRECTOR
Eisai Limited
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Fresno, California, United States
San Francisco, California, United States
Ventura, California, United States
Denver, Colorado, United States
Fort Collins, Colorado, United States
Washington D.C., District of Columbia, United States
Gulf Breeze, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Suwanee, Georgia, United States
Boise, Idaho, United States
Indianapolis, Indiana, United States
Ames, Iowa, United States
Lexington, Kentucky, United States
Houma, Louisiana, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Hattiesburg, Mississippi, United States
Chesterfield, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Albany, New York, United States
Buffalo, New York, United States
Great Neck, New York, United States
Lawrence, New York, United States
New York, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
Asheville, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Capital Federal, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
La Plata, Buenos Aires, , Argentina
Lanus Oeste, Buenos Aires, , Argentina
Rosario, , Argentina
Salta, , Argentina
San Miguel de Tucumán, , Argentina
Villa Nueva, , Argentina
Woodville, South Australia, Australia
Fitzroy, Victoria, Australia
Heidelberg, Victoria, Australia
Parkville, Victoria, Australia
Graz, , Austria
Innsbruck, , Austria
Linz, , Austria
Brussels, , Belgium
Leuven, , Belgium
Ottignies, , Belgium
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Calgary, Alberta, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Greenfield Park, Quebec, Canada
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Valdivia, , Chile
Beijing, , China
Chengdu, , China
Chongqing, , China
Shanghai, , China
Olomouc, , Czechia
Prague, , Czechia
Prague, , Czechia
Tallinn, , Estonia
Tartu, , Estonia
Kuopio, , Finland
Tampere, , Finland
Béthune, , France
Bron, , France
Montpellier, , France
Rennes, , France
Toulouse, , France
Berlin, , Germany
Bernau, , Germany
Bielefeld, , Germany
Bonn, , Germany
Düsseldorf, , Germany
Erlangen, , Germany
Göttingen, , Germany
Kehl-Kork, , Germany
Mainz, , Germany
Marburg, , Germany
München, , Germany
Ulm, , Germany
Westerstede, , Germany
Thessaloniki, , Greece
Thessaloniki, , Greece
Hong Kong, , Hong Kong
Kowloon, , Hong Kong
Pokfulam, , Hong Kong
Shatin, , Hong Kong
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Kecskemét, , Hungary
Hyderabad, , India
Hyderabad, , India
Jaipur, , India
Mangalore, , India
Mumbai, , India
Nagpur, , India
Nashik, , India
New Delhi, , India
Pune, , India
Pune, , India
Visakhapatnam, , India
Ashkelon, , Israel
Haifa, , Israel
Holon, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Florence, , Italy
Genova, , Italy
Milan, , Italy
Milan, , Italy
Napoli, , Italy
Riga, , Latvia
Riga, , Latvia
Valmiera, , Latvia
Kaunas, , Lithuania
Klaipėda, , Lithuania
Vilnius, , Lithuania
Kuala Lumpur, , Malaysia
Kuala Terengganu, , Malaysia
Aguascalientes, , Mexico
Mexico City, Distrito Federal, , Mexico
Monterrey, Nuevo Leon, , Mexico
San Luis Potosí City, , Mexico
Heeze, , Netherlands
Zwolle, , Netherlands
Ermita, , Philippines
Makati City, , Philippines
Bialystok, , Poland
Gdansk, , Poland
Gdansk, , Poland
Katowice, , Poland
Lublin, , Poland
Warsaw, , Poland
Coimbra, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Bucharest, , Romania
Bucharest, , Romania
Kazan', , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Omsk, , Russia
Samara, , Russia
Smolensk, , Russia
Tyumen, , Russia
Yaroslavl, , Russia
Yekaterinburg, , Russia
Belgrade, , Serbia
Niš, , Serbia
Novi Sad, , Serbia
Johannesburg, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Cape Town, , South Africa
Busan, , South Korea
Daegu, , South Korea
Pusan, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Granada, Andalusia, Spain
Barakaldo, Basque Country, Spain
Badalona, Catalonia, Spain
Barcelona, Catalonia, Spain
Barcelona, Catalonia, Spain
Alcorcón, Madrid, Communidad de, Spain
Madrid, Madrid, Communidad de, Spain
Valencia, Valencia, Spain
Gothenburg, , Sweden
Linköping, , Sweden
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taoyuan District, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Muang, , Thailand
Donetsk, , Ukraine
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Uzhhorod, , Ukraine
Liverpool, , United Kingdom
London, , United Kingdom
Middlesbrough, , United Kingdom
Stoke-on-Trent, , United Kingdom
Countries
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References
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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.
Krauss GL, Perucca E, Kwan P, Ben-Menachem E, Wang XF, Shih JJ, Patten A, Yang H, Williams B, Laurenza A. Final safety, tolerability, and seizure outcomes in patients with focal epilepsy treated with adjunctive perampanel for up to 4 years in an open-label extension of phase III randomized trials: Study 307. Epilepsia. 2018 Apr;59(4):866-876. doi: 10.1111/epi.14044. Epub 2018 Mar 25.
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.
Krauss GL, Perucca E, Ben-Menachem E, Kwan P, Shih JJ, Clement JF, Wang X, Bagul M, Gee M, Zhu J, Squillacote D. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarily generalized seizures: results from phase III extension study 307. Epilepsia. 2014 Jul;55(7):1058-68. doi: 10.1111/epi.12643. Epub 2014 May 27.
Other Identifiers
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E2007-G000-307
Identifier Type: -
Identifier Source: org_study_id
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