Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
- Conditions
- Parkinson's Disease
- Interventions
- Drug: placebo comparatorDrug: 2 mg perampanelDrug: 4 mg perampanel
- Registration Number
- NCT00368108
- Lead Sponsor
- Eisai Inc.
- Brief Summary
This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study of E2007 in levodopa treated Parkinson's disease patients with motor fluctuations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 752
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo comparator The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening. 2 mg perampanel 2 mg perampanel The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening. 4 mg perampanel 4 mg perampanel The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data) Baseline and Week 20 Patients described themselves in home diaries as "OFF", "ON" without dyskinesias, "ON" with non troublesome dyskinesias, "ON" with troublesome dyskinesias, or Asleep, every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 10, 18, and 20. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data) Baseline and Week 20 Patients described themselves in home diaries every 30 minutes during waking hours for 3 consecutive days prior to Baseline, Weeks 8, 12, 16, and 20. Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data) Baseline and Week 20 Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. UPDRS is a standardized assessment of the symptoms and signs of PD. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. ON state is when medication is providing benefits to stiffness, slowness, and tremor.
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data) Baseline and Week 20 Patients described themselves in home diaries every 30 minutes during waking hours for 3 days prior to Baseline, Weeks 8, 12, 16, and 20. ON state is when medication is providing benefits to stiffness, slowness, and tremor.
Trial Locations
- Locations (114)
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Harvard Vanguard Medical Associates
🇺🇸Boston, Massachusetts, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Kansas
🇺🇸Kansas City, Kansas, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Pacific Parkinson Research Centre
🇨🇦Vancouver, British Columbia, Canada
University Of Kentucky
🇺🇸Lexington, Kentucky, United States
University of California San Francisco Medical Center
🇺🇸San Francisco, California, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Oklahoma - Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Neurology Associates
🇺🇸San Antonio, Texas, United States
Mile High Research Center
🇺🇸Denver, Colorado, United States
University Of Colorado
🇺🇸Denver, Colorado, United States
Creighton University - Department of Neurology
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Wisconsin Institute for Neurologic and Sleep Disorders
🇺🇸Milwaukee, Wisconsin, United States
Associated Neurologists, PC - Danbury
🇺🇸Danbury, Connecticut, United States
Clinical Trials Inc.
🇺🇸Little Rock, Arkansas, United States
North Alabama Neuroscience Research Associates
🇺🇸Huntsville, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
The Parkinson's and Movement Disorder Institute
🇺🇸Fountain Valley, California, United States
Margolin Brain Institute
🇺🇸Fresno, California, United States
Pivotal Research Centers
🇺🇸Peoria, Arizona, United States
The Parkinson's Institute
🇺🇸Sunnyvale, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Suncoast Neuroscience Associates, Inc.
🇺🇸St. Petersburg, Florida, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Pacific Neuroscience Medical Group, Inc.
🇺🇸Oxnard, California, United States
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Parkinson's Disease and Movement Disorder Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
Sunrise Clinical Research
🇺🇸Hollywood, Florida, United States
Cleveland Clinic Florida - Weston
🇺🇸Weston, Florida, United States
Dekalb Neurology Associates, LLC/DNA Research
🇺🇸Decatur, Georgia, United States
LSUHSC-Shreveport
🇺🇸Shreveport, Louisiana, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
OSF Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Fort Wayne Neurological Center
🇺🇸Fort Wayne, Indiana, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
Parkinson's and Movement Disorders Center of Maryland
🇺🇸Elkridge, Maryland, United States
Quest Research Institute
🇺🇸Bingham Farms, Michigan, United States
Albany Medical College
🇺🇸Albany, New York, United States
The Clinical Neurosciences Center
🇺🇸Southfield, Michigan, United States
Northern Michigan Neurology
🇺🇸Traverse City, Michigan, United States
Struthers Parkinson's Center
🇺🇸Golden Valley, Minnesota, United States
Columbia University
🇺🇸New York, New York, United States
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
North Shore Medical Center
🇺🇸Manhasset, New York, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Northwest NeuroSpecialists, PLLC
🇺🇸Tucson, Arizona, United States
University of Miami
🇺🇸Miami, Florida, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Palm Beach Neurological Center
🇺🇸Palm Beach Gardens, Florida, United States
Coastal Neurological Group
🇺🇸La Jolla, California, United States
University of California Medical Center - Irvine
🇺🇸Irvine, California, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
University of California at San Diego - Department of Neurology
🇺🇸La Jolla, California, United States
Loma Linda University
🇺🇸Loma Linda, California, United States
UAMS Department of Neurology
🇺🇸Little Rock, Arkansas, United States
Colorado Neurology
🇺🇸Englewood, Colorado, United States
University of Florida - Department of Neurology
🇺🇸Jacksonville, Florida, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Gil, Ramon A.
🇺🇸Port Charlotte, Florida, United States
Northwestern University Medical School
🇺🇸Chicago, Illinois, United States
University Of Iowa
🇺🇸Iowa City, Iowa, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Washington University
🇺🇸St. Louis, Missouri, United States
University of Nevada School of Medicine
🇺🇸Las Vegas, Nevada, United States
University of Medicine and Dentistry of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Parkinson's Disease and Movement Disorder Center of Long Island
🇺🇸Commack, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
New York University Medical Center
🇺🇸Forest Hills, New York, United States
Asheville Neurology Specialists
🇺🇸Asheville, North Carolina, United States
University of Rochester - Neurology Clinic
🇺🇸Rochester, New York, United States
The Mount Sinai Medical Center
🇺🇸New York, New York, United States
Asheville Neurology Specialists. PA
🇺🇸Asheville, North Carolina, United States
Raleigh Neurology Associates, P.A.
🇺🇸Raleigh, North Carolina, United States
The University of Toledo College of Medicine
🇺🇸Toledo, Ohio, United States
Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Neurology Specialists, Inc.
🇺🇸Dayton, Ohio, United States
Radiant Research - Dallas North
🇺🇸Dallas, Texas, United States
Agape' Medical Center, Inc.
🇺🇸Lubbock, Texas, United States
Crozer Medical Center
🇺🇸Upland, Pennsylvania, United States
Semmes Murphey Neurology and Spine Institute
🇺🇸Memphis, Tennessee, United States
Bhupesh Dihenia, MD, PA
🇺🇸Lubbock, Texas, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Capitol Neurology
🇺🇸Charleston, West Virginia, United States
Neurology and Neurosurgery Associates of Tacoma, PLLC
🇺🇸Tacoma, Washington, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of Calgary
🇨🇦Calgary, Alberta, Canada
Centre For Movement Disorders
🇨🇦Markham, Ontario, Canada
David King, MD
🇨🇦Halifax, Nova Scotia, Canada
Parkinson's and Neurodegenerative Disorders Clinic
🇨🇦Ottawa, Ontario, Canada
Saint John Regional Hospital, 5DN
🇨🇦Saint John, New Brunswick, Canada
Torotnto Western Hospital-University Health Network
🇨🇦Toronto, Ontario, Canada
The Ottawa Hospital - Civic Campus
🇨🇦Ottawa, Ontario, Canada
CHUM- Hotel-Dieu
🇨🇦Montreal, Quebec, Canada
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
Clinique Neuro Rive-Sud
🇨🇦Greenfield Park, Quebec, Canada
SMBD Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Quebec Memory and Motor Skills Disorders Clinic
🇨🇦Quebec, Canada
Molecular Neuroimaging, LLC
🇺🇸New Haven, Connecticut, United States
University Of South Florida Movement Disorders Clinic
🇺🇸Tampa, Florida, United States
Kentucky Neuroscience Research
🇺🇸Louisville, Kentucky, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Hunter Holmes McGuire
🇺🇸Richmond, Virginia, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States