Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

NCT00735397 | Completed Phase 3 Results DMC

• 1 other identifier: E2007-G000-307
• Study Type: interventional
• Target: 1,218
• Locations: 36 countries
• Sites: 226

Brief Summary

The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.

Conditions

Epilepsy

Keywords

Partial onset seizures

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)

  An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.

  From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years.

Secondary Outcomes (2)

• Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.

  Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, and 248-260)

• Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.

  Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, 248-260)

Study Arms (1)

Perampanel

EXPERIMENTAL

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.

Drug: perampanel

Interventions

perampanel DRUG

Perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years

Perampanel

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Each participant who met the following criteria were enrolled in this study:

You may not qualify if:

• Provided written informed consent signed by participant or legal guardian prior to entering the study or undergoing any study procedures (If the written informed consent was provided by the legal guardian because the participant was unable to do so, a written or verbal assent from the participant was obtained).
• 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.
• 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).
• 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:
• \. Those who, for any reason, discontinued early from the preceding double-blind study.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (239)

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Birmingham, Alabama, 35294, United States

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Phoenix, Arizona, 85004, United States

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Phoenix, Arizona, 85013, United States

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Tucson, Arizona, 85724, United States

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Little Rock, Arkansas, 72205, United States

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Fresno, California, 93710, United States

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San Francisco, California, 94115, United States

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Ventura, California, 93003, United States

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Denver, Colorado, 80218, United States

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Fort Collins, Colorado, 80525, United States

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Washington D.C., District of Columbia, 20010, United States

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Gulf Breeze, Florida, 32561, United States

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Jacksonville, Florida, 32209, United States

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Jacksonville, Florida, 32224, United States

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Orlando, Florida, 32819, United States

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Tallahassee, Florida, 32308, United States

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Tampa, Florida, 33609, United States

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Atlanta, Georgia, 30342, United States

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Suwanee, Georgia, 30024, United States

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Boise, Idaho, 83702, United States

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Indianapolis, Indiana, 46256, United States

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Ames, Iowa, 50010, United States

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Lexington, Kentucky, 40536, United States

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Houma, Louisiana, 70363, United States

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Baltimore, Maryland, 21287-7247, United States

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Bethesda, Maryland, 20817, United States

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Hattiesburg, Mississippi, 39401, United States

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Chesterfield, Missouri, 63017, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63110, United States

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Albany, New York, 12208, United States

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Buffalo, New York, 14222, United States

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Great Neck, New York, 11021, United States

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Lawrence, New York, 11559, United States

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New York, New York, 10016, United States

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Rochester, New York, 14642, United States

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Syracuse, New York, 13210, United States

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Asheville, North Carolina, 28806, United States

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Akron, Ohio, 44308, United States

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Cincinnati, Ohio, 45219, United States

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Columbus, Ohio, 43221, United States

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Toledo, Ohio, 43614, United States

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Tulsa, Oklahoma, 74137, United States

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Portland, Oregon, 97210, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Charleston, South Carolina, 29425, United States

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Memphis, Tennessee, 38105, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75235, United States

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Dallas, Texas, 75251, United States

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El Paso, Texas, 79905, United States

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Houston, Texas, 77030, United States

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Salt Lake City, Utah, 84108, United States

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Richmond, Virginia, 23298, United States

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Seattle, Washington, 98104, United States

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Madison, Wisconsin, 53715, United States

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Buenos Aires, C1117ABE, Argentina

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Buenos Aires, C1122AAK, Argentina

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Buenos Aires, C1182ACD, Argentina

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Buenos Aires, C1221ADC, Argentina

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Buenos Aires, C1280AEB, Argentina

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Buenos Aires, C1406FWY, Argentina

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Capital Federal, 1428, Argentina

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Córdoba, X5000JJS, Argentina

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Córdoba, X5010AOC, Argentina

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La Plata, Buenos Aires, B1902AHD, Argentina

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Lanus Oeste, Buenos Aires, B1824CWE, Argentina

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Rosario, S2000DSV, Argentina

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Salta, A4402AYT, Argentina

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San Miguel de Tucumán, T4000DVD, Argentina

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Villa Nueva, M5519FNF, Argentina

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Woodville, South Australia, 5011, Australia

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Fitzroy, Victoria, 3065, Australia

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Heidelberg, Victoria, 3084, Australia

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Parkville, Victoria, 3050, Australia

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Linz, A-4021, Austria

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Brussels, 1070, Belgium

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Leuven, 3000, Belgium

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Ottignies, 1340, Belgium

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Sofia, 1113, Bulgaria

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Sofia, 1606, Bulgaria

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Calgary, Alberta, T2N 2T9, Canada

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London, Ontario, N6A 5A5, Canada

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Toronto, Ontario, M5B 1T9, Canada

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Greenfield Park, Quebec, J4V 2J2, Canada

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Santiago, 3459, Chile

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Santiago, 8260094, Chile

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Santiago, 8900085, Chile

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Valdivia, 5090145, Chile

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Beijing, 100730, China

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Chengdu, 610041, China

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Chongqing, 400016, China

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Shanghai, 200040, China

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Olomouc, 775 20, Czechia

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Prague, 140 59, Czechia

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Prague, 150 06, Czechia

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Tallinn, EE-13419, Estonia

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Tartu, EE-51014, Estonia

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Kuopio, FI-70210, Finland

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Tampere, FI-33520, Finland

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Béthune, 62408, France

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Bron, 69677, France

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Montpellier, 34295, France

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Rennes, 35033, France

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Toulouse, 31059, France

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Berlin, 10117, Germany

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Bernau, 16321, Germany

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Bielefeld, 33617, Germany

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Bonn, 53127, Germany

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Düsseldorf, 40212, Germany

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Erlangen, 91054, Germany

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Göttingen, 37075, Germany

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Kehl-Kork, 77694, Germany

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Mainz, 55131, Germany

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Marburg, 35039, Germany

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München, 81377, Germany

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Ulm, 89081, Germany

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Westerstede, 26655, Germany

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Thessaloniki, 546 36, Greece

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Thessaloniki, 57010, Greece

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Hong Kong, Hong Kong

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Kowloon, Hong Kong

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Pokfulam, 852, Hong Kong

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Shatin, Hong Kong

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Budapest, 1097, Hungary

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Budapest, 1136, Hungary

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Budapest, 1145, Hungary

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Budapest, H-1143, Hungary

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Kecskemét, 6000, Hungary

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Hyderabad, 500001, India

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Hyderabad, 500082, India

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Jaipur, 302004, India

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Mangalore, 575002, India

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Mumbai, 400026, India

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Nagpur, 440010, India

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Nashik, 422004, India

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New Delhi, 110060, India

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Pune, 411011, India

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Pune, 411030, India

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Visakhapatnam, 530002, India

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Ashkelon, 78278, Israel

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Haifa, 31096, Israel

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Holon, 58100, Israel

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Kfar Saba, 44281, Israel

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Petah Tikva, 49202, Israel

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Ramat Gan, 52621, Israel

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Florence, 50134, Italy

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Genova, 16147, Italy

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Milan, 20121, Italy

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Milan, 20133, Italy

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Napoli, 80131, Italy

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Riga, LV-1004, Latvia

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Riga, LV-1038, Latvia

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Valmiera, LV-4201, Latvia

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Kaunas, LT-50009, Lithuania

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Klaipėda, LT-92288, Lithuania

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Vilnius, LT-08661, Lithuania

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Kuala Lumpur, 59100, Malaysia

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Kuala Terengganu, 20400, Malaysia

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Aguascalientes, 20127, Mexico

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Mexico City, Distrito Federal, 14050, Mexico

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Monterrey, Nuevo Leon, 64000, Mexico

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San Luis Potosí City, 78240, Mexico

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Heeze, 5591 VE, Netherlands

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Zwolle, 8025 BV, Netherlands

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Ermita, 1000, Philippines

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Makati City, 1229, Philippines

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Bialystok, 15-276, Poland

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Gdansk, 80-803, Poland

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Gdansk, 80-952, Poland

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Katowice, 40-635, Poland

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Lublin, 20-718, Poland

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Warsaw, 02-957, Poland

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Coimbra, 3000-075, Portugal

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Lisbon, 1649-035, Portugal

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Porto, 4200-319, Portugal

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Bucharest, 20125, Romania

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Bucharest, Romania

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Kazan', 420097, Russia

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Moscow, 107066, Russia

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Moscow, 107076, Russia

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Moscow, 119992, Russia

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Moscow, 125412, Russia

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Nizhny Novgorod, 603005, Russia

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Omsk, 644001, Russia

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Samara, 443095, Russia

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Smolensk, 214018, Russia

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Tyumen, 625039, Russia

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Yaroslavl, 150030, Russia

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Yekaterinburg, 620149, Russia

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Belgrade, 11000, Serbia

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Niš, 18000, Serbia

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Novi Sad, 21000, Serbia

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Johannesburg, Gauteng, 2196, South Africa

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Cape Town, Western Cape, 7925, South Africa

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Cape Town, 7500, South Africa

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Busan, 614735, South Korea

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Daegu, 700712, South Korea

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Pusan, 602715, South Korea

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Seoul, 110744, South Korea

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Seoul, 120752, South Korea

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Seoul, 135710, South Korea

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Seoul, 138736, South Korea

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Granada, Andalusia, 18012, Spain

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Barakaldo, Basque Country, 48903, Spain

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Badalona, Catalonia, 8916, Spain

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Barcelona, Catalonia, 8003, Spain

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Barcelona, Catalonia, 8025, Spain

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Alcorcón, Madrid, Communidad de, 28922, Spain

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Madrid, Madrid, Communidad de, 28040, Spain

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Valencia, Valencia, 46009, Spain

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Gothenburg, Sweden

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Linköping, Sweden

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Kaohsiung City, 833, Taiwan

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Taichung, 40705, Taiwan

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Tainan, 70403, Taiwan

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Taoyuan District, 333, Taiwan

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Bangkok, 10330, Thailand

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Chiang Mai, 50200, Thailand

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Muang, 40002, Thailand

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Donetsk, 83052, Ukraine

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Donetsk, 83114, Ukraine

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Kharkiv, 61018, Ukraine

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Kharkiv, 61068, Ukraine

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Kyiv, 4080, Ukraine

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Kyiv, 4209, Ukraine

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Lviv, 79010, Ukraine

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Uzhhorod, 88000, Ukraine

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Liverpool, L9 7LJ, United Kingdom

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London, SW17 0QT, United Kingdom

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Middlesbrough, TS4 3BW, United Kingdom

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Stoke-on-Trent, ST4 7LN, United Kingdom

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Related Publications (4)

• 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.

  PMID: 35305920 DERIVED

• 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.

  PMID: 29574701 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.

  PMID: 25823975 DERIVED

• 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.

  PMID: 24867391 DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Eisai Call Center
• Organization: Eisai Inc.

888-422-4743

Study Officials

• Michelle Gee, PhD.

  Eisai Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 14, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 14, 2016
• Results First Posted: January 26, 2016

Record last verified: 2016-02

Locations

BE (3); NL (2); HU (5); PL (6); AU (4); SE (3); AR (15); CN (4); RO (2); TH (5); LI (3); CA (4); GR (2); FI (2); RU (12); IT (5); IN (11); PH (2); PT (3); KR (7); TW (4); BU (4); HK (4); CZ (3); ES (2); GB (4); FR (5); DE (13); LA (3); UA (8); CL (4); US (57); ZA (3); IL (6); MY (2); ME (4)