Evaluating the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
- Conditions
- Refractory Partial Seizures
- Interventions
- Drug: E2007 (perampanel)Drug: Placebo
- Registration Number
- NCT00699972
- Lead Sponsor
- Eisai Inc.
- Brief Summary
The purpose of this study is to evaluate the safety, efficacy and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 390
Not provided
Subjects who meet any of the following criteria will be excluded from the study:
- 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.
- Pregnant and/or lactating.
- Participated in previous perampanel studies.
- Presence of nonmotor simple partial seizures only.
- Presence of primary generalized epilepsies or seizures, such as absences and or myoclonic epilepsies.
- Presence or previous history of Lennox-Gastaut syndrome.
- A history of status epilepticus within approximately 12 months prior to Visit 1.
- Seizure clusters where individual seizures cannot be counted.
- A history of psychogenic seizures.
- 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.
- 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.
- 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).
- 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).
- A clinically significant electrocardiogram (ECG) abnormality, including prolonged QTc defined as >450 msec.
- 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.
- Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
- History of drug or alcohol dependency or abuse within approximately the last 2 years.
- 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.
- 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.
- 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.
- Concomitant use of barbiturates (except for seizure control indication) within 1 month (or no less than 21 days) prior to Visit 1.
- 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
- Any condition(s) that will make the subject, in the opinion of the Investigator, unsuitable for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 E2007 (perampanel) - 3 Placebo - 1 E2007 (perampanel) -
- Primary Outcome Measures
Name Time Method Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) Baseline (Pre-randomization) through Week 19 Seizure frequency per 28 days was derived from the information recorded in the subject diaries.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Were Responders Baseline (Pre-randomization) through Week 19 A responder was a participant who had a 50 percent or greater reduction in seizure frequency per 28 days from the Pre-randomization phase.
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) Baseline (Pre-randomization) through Week 19 Percent Change in the Seizure frequency per 28 days was derived from the information recorded in the subject diaries.
Trial Locations
- Locations (94)
Neurology/Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University Neurology, Inc.
🇺🇸Cincinnati, Ohio, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Via Christi Comprehensive Epilepsy Center
🇺🇸Wichita, Kansas, United States
Louisiana State University Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Children's Healthcare of Atlanta at Scottish Rite
🇺🇸Atlanta, Georgia, United States
Children's Research Institute
🇺🇸Washington, District of Columbia, United States
North West Florida Clinical Research Group
🇺🇸Pensacola, Florida, United States
Josephson Wallack Munshower Neurology
🇺🇸Indianapolis, Indiana, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Tallahassee Neurological Clinic
🇺🇸Tallahassee, Florida, United States
PANDA
🇺🇸Atlanta, Georgia, United States
Child Neurology Center Of Nw Florida
🇺🇸Pensacola, Florida, United States
Ronald Aung-Din, MD, PC
🇺🇸Sarasota, Florida, United States
Five Towns Neurology, PC
🇺🇸Cedarhurst, New York, United States
Asheville Neurology Specialists, PA
🇺🇸Asheville, North Carolina, United States
Neurological Clinic of Texas, P.A.
🇺🇸Dallas, Texas, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Children's Hospital Medical Center Of Akron D/B/A Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Neurological Associates of Tulsa, Inc.
🇺🇸Tulsa, Oklahoma, United States
Providence St. Vincent's Epilepsy Center
🇺🇸Portland, Oregon, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mile High Research Center
🇺🇸Denver, Colorado, United States
St. Joseph's Hospital And Medical Center
🇺🇸Phoenix, Arizona, United States
Bright Minds Institute
🇺🇸San Francisco, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Albany Medical College
🇺🇸Albany, New York, United States
Clinical Trials, Inc.
🇺🇸Little Rock, Arkansas, United States
Pediatric Neurology and Epilepsy Center
🇺🇸Loxahatchee Groves, Florida, United States
University of Florida Health Sciences, Jacksonville
🇺🇸Jacksonville, Florida, United States
Georgia Neurology and Sleep Medicine Associates
🇺🇸Suwanee, Georgia, United States
University of Kentucky Research Foundation
🇺🇸Lexington, Kentucky, United States
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
Michigan Neurology Associates, P.C.
🇺🇸Clinton Township, Michigan, United States
Univeristy of Rochester Strong Epilepsy Center
🇺🇸Rochester, New York, United States
University Of Toledo Medical Center
🇺🇸Toledo, Ohio, United States
Blair Medical Assiciates, Inc.
🇺🇸Altoona, Pennsylvania, United States
UT Le Bonheur Pediatric Specialists
🇺🇸Memphis, Tennessee, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
Hospital San Roque
🇦🇷Córdoba, Córdoba- Provincia De Córdoba, Argentina
Sanatorio Allende
🇦🇷Córdoba, Provincia De Córdoba, Argentina
Hospital Santa Clara de Asis
🇦🇷Salta, Provincia De Salta, Argentina
Hospital de Niños Ricardo Gutiérrez
🇦🇷Capital Federal- Provincia de Buenos Aires, Argentina
Hospital General de Agudos Teodoro Álvarez
🇦🇷Capital Federal- Provincia de Buenos Aires, Argentina
Sanatorio Parque
🇦🇷Rosario, Argentina
Centro de Estudio y Tratamiento de la Epilepsia y Sueño- CETES S.A.
🇦🇷Córdoba, Argentina
Policlínica Bancaria 9 de Julio
🇦🇷Capital Federal- Provincia de Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Capital Federal- Provincia de Buenos Aires, Argentina
Faculdade de Ciências Médicas - UNICAMP
🇧🇷Campinas, 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
Youthdale Treatment Centers
🇨🇦Toronto, Ontario, Canada
Foothills Medical Center
🇨🇦Calgary, Alberta, Canada
London Health Sciences Center
🇨🇦London, Ontario, Canada
Neuro Rive-Sud
🇨🇦Greenfield Park, Quebec, Canada
CHU Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Sarug Reyes
🇲🇽Aguascalientes, Mexico
Hospital Dr. Sótero del Río
🇨🇱Santiago, Chile
Instituto Biomedico de Investigacion AC
🇲🇽Aguascalientes, Mexico
Medica Sur SIF-BIOTEC
🇲🇽Mexico City, Mexico
Hospital Central "Dr. Ignacio Morones Prieto"
🇲🇽San Luis Potosi, Mexico
Leonard J. Chabert Medical Center
🇺🇸Houma, Louisiana, United States
Hospital Británico
🇦🇷Capital Federal- Provincia de Buenos Aires, Argentina
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Lovelace Scientific Resources
🇺🇸Sarasota, Florida, United States
Children's Hospital Of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Dallas Pediatric Neurology Associates
🇺🇸Dallas, Texas, United States
FLENI (Fundación para la Lucha Contra Las Enfermedades Neurológicas de La Infancia)
🇦🇷Capital Federal- Provincia de Buenos Aires, Argentina
Hospital General de Agudos José María Ramos Mejia
🇦🇷Capital Federal- Provincia de Buenos Aires, Argentina
Hospital de Clinicas da UFPR
🇧🇷Curitiba, Brazil
Santa Casa de Porto Alegre
🇧🇷Porto Alegre, Brazil
Hospital Barros Luco Trudeau
🇨🇱Santiago, Chile
Hospital Base Valdivia Servicio de Neurología
🇨🇱Santiago, Chile
Neuropsicología Ltda.
🇨🇱Santiago, Chile
MIRC
🇲🇽Monterrey, Nuevo Leon CP, Mexico
Mid-Atlantic Epilepsy and Sleep Center
🇺🇸Bethesda, Maryland, United States
Pediatric Neurology PA
🇺🇸Orlando, Florida, United States
Pediatric Epilepsy and Neurology Specialists
🇺🇸Tampa, Florida, United States
Regional Epilepsy Center
🇺🇸Milwaukee, Wisconsin, United States
Kentucky Neuroscience Research
🇺🇸Louisville, Kentucky, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States