Evaluating the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
NCT ID: NCT00699972
Last Updated: 2020-01-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
390 participants
INTERVENTIONAL
2008-04-30
2010-10-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
E2007 (perampanel)
8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.
2
E2007 (perampanel)
12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.
3
Placebo
Placebo in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study.
Interventions
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E2007 (perampanel)
8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.
E2007 (perampanel)
12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.
Placebo
Placebo in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Provide written informed consent signed by the subject or legal guardian prior to entering the study or undergoing any study procedures (If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained).
2. Be considered reliable and willing to be available for the study period and able to record seizures and report Adverse Events (AEs) them self or have a caregiver who can record seizures and report AEs for them.
3. Male or female and greater than or equal to 12 years of age (within the course of the study).
4. Females should be 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 must have a negative serum Beta Human Chorionic Gonadotropin (ß-hCG) at Visit 1 and a negative urine pregnancy test prior to randomization at Visit 2. Female subjects of childbearing potential must agree to be abstinent or to use 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) starting at Visit 1 and throughout the entire study period and for 2 months after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously) starting at Visit 1 and continuing throughout the entire study period and for 2 months after the last dose of study drug. (It is not required for male subjects to use contraceptive measures based on preclinical toxicology data).
5. Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and an electroencephalogram (EEG) that is consistent with localization-related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history).
6. Have had a computed tomography (CT) or magnetic resonance imaging (MRI) within the last 10 years that ruled out a progressive cause of epilepsy.
7. Have uncontrolled partial seizures despite having been treated with at least 2 different anti-epileptic drugs (AEDs) within approximately the last 2 years.
8. During the 6-week Pre-randomization Phase subjects must have had ≥5 partial seizures per 6-week (with ≥2 partial seizures per each of 3-week period) and with no 25-day seizure-free period in the 6-week period, as documented via a valid seizure diary. Only simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with secondary generalization are counted toward this inclusion.
9. Are currently being treated with stable doses of 1, 2 or a maximum of 3 approved AEDs. Only 1 inducer AED (defined as; carbamazepine, phenytoin, phenobarbital, or primidone only) out of the maximum of 3 AEDs is allowed.
10. Are on a stable dose of the same concomitant AED(s) for 1 month (or no less than 21 days) prior to Visit 1; in the case where a new AED regime has been initiated for a subject, the dose must be stable for 2 months (or no less than 49 days) prior to Visit 1.
11. If on a stable dose (other than intermittent rescue use) of benzodiazepines for epilepsy (or for anxiety or sleep disorders) the prescribed dose must be stable for 1 month (or no less than 21 days) prior to Visit 1. (Note: the use of intermittent rescue benzodiazepines is defined in the exclusion criterion #22 below.) When used in these cases (epilepsy, anxiety or sleep disorders), benzodiazepines will be counted as 1 AED; therefore, only 1 or a maximum of 2 additional approved AEDs will be allowed.
12. A vagal nerve stimulator (VNS) is allowed but it must have been implanted ≥5 months prior to Visit 1. Stimulator parameters can not be changed for 1 month (or no less than 21 days) prior to Visit 1 or thereafter during the study.
Exclusion Criteria
1. Participated in a study involving administration of an investigational compound or device within 1 month (or no less than 21 days) prior to Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer.
2. Pregnant and/or lactating.
3. Participated in previous perampanel studies.
4. Presence of nonmotor simple partial seizures only.
5. Presence of primary generalized epilepsies or seizures, such as absences and or myoclonic epilepsies.
6. Presence or previous history of Lennox-Gastaut syndrome.
7. A history of status epilepticus within approximately 12 months prior to Visit 1.
8. Seizure clusters where individual seizures cannot be counted.
9. A history of psychogenic seizures.
10. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject's safety or the study conduct.
11. Scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however those who have previously documented "failed" epilepsy surgery will be allowed.
12. Evidence of significant active hepatic disease. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if they are less than 3 times the upper limit of normal (ULN).
13. Evidence of significant active hematological disease; white blood cell (WBC) count \<= 2500/µL (2.50 1E+09/L) or an absolute neutrophil count \<= 1000/µL (1.00 1E+09/L).
14. A clinically significant electrocardiogram (ECG) abnormality, including prolonged QTc defined as \>450 msec.
15. Suffering from psychotic disorder(s) and/or unstable recurrent affective disorder(s) evident by use of antipsychotics or have had a suicide attempt(s) within approximately the last 2 years.
16. Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
17. History of drug or alcohol dependency or abuse within approximately the last 2 years.
18. Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
19. If felbamate is used as a concomitant AED, subjects must be on felbamate for at least 2 years, with a stable dose for 2 months (or no less than 49 days) prior to Visit 1. They must not have a history of white blood cell (WBC) count below 2500/µL (2.50 1E+09/L), platelets below 100,000, liver function tests (LFTs) above 3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If subjects received felbamate in the past, it must have been discontinued 2 months (or no less than 49 days) prior to Visit 1.
20. Concomitant use of vigabatrin. Subjects who took vigabatrin in the past must be off vigabatrin for approximately 5 months prior to Visit 1 and must have documentation showing no evidence of a vigabatrin associated clinically significant abnormality in a visual perimetry test.
21. Concomitant use of barbiturates (except for seizure control indication) within 1 month (or no less than 21 days) prior to Visit 1.
22. Use of intermittent rescue benzodiazepines (ie, 1-2 doses over a 24-hr period considered one-time rescue) 2 or more times in a 1-month period prior to Visit 1; or
23. Any condition(s) that will make the subject, in the opinion of the Investigator, unsuitable for the study.
12 Years
99 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Squillacote, M.D.
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
St. Joseph's Hospital And Medical Center
Phoenix, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Bright Minds Institute
San Francisco, California, United States
California Pacific Medical Center
San Francisco, California, United States
Mile High Research Center
Denver, Colorado, United States
Children's Research Institute
Washington D.C., District of Columbia, United States
University of Florida Health Sciences, Jacksonville
Jacksonville, Florida, United States
Pediatric Neurology and Epilepsy Center
Loxahatchee Groves, Florida, United States
Loxahatchee Groves, Florida, United States
Pediatric Neurology PA
Orlando, Florida, United States
North West Florida Clinical Research Group
Pensacola, Florida, United States
Child Neurology Center Of Nw Florida
Pensacola, Florida, United States
Lovelace Scientific Resources
Sarasota, Florida, United States
Ronald Aung-Din, MD, PC
Sarasota, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States
PANDA
Atlanta, Georgia, United States
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, United States
Georgia Neurology and Sleep Medicine Associates
Suwanee, Georgia, United States
Josephson Wallack Munshower Neurology
Indianapolis, Indiana, United States
McFarland Clinic, PC
Ames, Iowa, United States
Via Christi Comprehensive Epilepsy Center
Wichita, Kansas, United States
Wichita, Kansas, United States
University of Kentucky Research Foundation
Lexington, Kentucky, United States
Kentucky Neuroscience Research
Louisville, Kentucky, United States
Leonard J. Chabert Medical Center
Houma, Louisiana, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
Neurology/Johns Hopkins Hospital
Baltimore, Maryland, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Boston University Medical Center
Boston, Massachusetts, United States
Michigan Neurology Associates, P.C.
Clinton Township, Michigan, United States
Washington University
St Louis, Missouri, United States
Albany Medical College
Albany, New York, United States
Five Towns Neurology, PC
Cedarhurst, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Univeristy of Rochester Strong Epilepsy Center
Rochester, New York, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, United States
Children's Hospital Medical Center Of Akron D/B/A Akron Children's Hospital
Akron, Ohio, United States
University Neurology, Inc.
Cincinnati, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
University Of Toledo Medical Center
Toledo, Ohio, United States
Neurological Associates of Tulsa, Inc.
Tulsa, Oklahoma, United States
Providence St. Vincent's Epilepsy Center
Portland, Oregon, United States
Blair Medical Assiciates, Inc.
Altoona, Pennsylvania, United States
Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
UT Le Bonheur Pediatric Specialists
Memphis, Tennessee, United States
Dallas Pediatric Neurology Associates
Dallas, Texas, United States
Neurological Clinic of Texas, P.A.
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Regional Epilepsy Center
Milwaukee, Wisconsin, United States
Sanatorio Allende
Córdoba, Córdoba Province, Argentina
Hospital San Roque
Córdoba, Córdoba- Provincia de Córdoba, Argentina
Hospital Santa Clara de Asis
Salta, Salta Province, Argentina
FLENI (Fundación para la Lucha Contra Las Enfermedades Neurológicas de La Infancia)
Capital Federal- Provincia de Buenos Aires, , Argentina
Hospital Británico
Capital Federal- Provincia de Buenos Aires, , Argentina
Hospital de Niños Ricardo Gutiérrez
Capital Federal- Provincia de Buenos Aires, , Argentina
Hospital General de Agudos José María Ramos Mejia
Capital Federal- Provincia de Buenos Aires, , Argentina
Hospital General de Agudos Teodoro Álvarez
Capital Federal- Provincia de Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Capital Federal- Provincia de Buenos Aires, , Argentina
Policlínica Bancaria 9 de Julio
Capital Federal- Provincia de Buenos Aires, , Argentina
Centro de Estudio y Tratamiento de la Epilepsia y Sueño- CETES S.A.
Córdoba, , Argentina
Sanatorio Parque
Rosario, , Argentina
Faculdade de Ciências Médicas - UNICAMP
Campinas, , Brazil
Hospital de Clinicas da UFPR
Curitiba, , Brazil
Santa Casa de Porto Alegre
Porto Alegre, , Brazil
HC Ribeirão Preto
Ribeirão Preto, , Brazil
Hospital Pedro Ernesto - UERJ
Rio de Janeiro, , Brazil
Hospital Universitário Professor Edgar Santos
Salvador, , Brazil
Faculdade de Medicinade São José do Rio preto
São José do Rio Preto, , Brazil
HC-FMUSP
São Paulo, , Brazil
Hospital Brigadeiro
São Paulo, , Brazil
Hospital Santa Marcelina
São Paulo, , Brazil
UNIFESP
São Paulo, , Brazil
Foothills Medical Center
Calgary, Alberta, Canada
London Health Sciences Center
London, Ontario, Canada
Youthdale Treatment Centers
Toronto, Ontario, Canada
Neuro Rive-Sud
Greenfield Park, Quebec, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
Hospital Barros Luco Trudeau
Santiago, , Chile
Hospital Base Valdivia Servicio de Neurología
Santiago, , Chile
Hospital Dr. Sótero del Río
Santiago, , Chile
Neuropsicología Ltda.
Santiago, , Chile
MIRC
Monterrey, Nuevo Leon CP, Mexico
Instituto Biomedico de Investigacion AC
Aguascalientes, , Mexico
Sarug Reyes
Aguascalientes, , Mexico
Medica Sur SIF-BIOTEC
Mexico City, , Mexico
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, , Mexico
Countries
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References
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French JA, Krauss GL, Biton V, Squillacote D, Yang H, Laurenza A, Kumar D, Rogawski MA. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology. 2012 Aug 7;79(6):589-96. doi: 10.1212/WNL.0b013e3182635735. Epub 2012 Jul 25.
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.
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.
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.
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.
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.
Other Identifiers
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E2007-G000-304
Identifier Type: -
Identifier Source: org_study_id
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