Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
1 other identifier
interventional
752
2 countries
114
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2006
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 22, 2006
CompletedFirst Posted
Study publicly available on registry
August 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
February 5, 2013
CompletedMay 20, 2013
January 1, 2013
1.4 years
August 22, 2006
October 23, 2012
May 13, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)
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.
Baseline and Week 20
Secondary Outcomes (3)
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
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data)
Baseline and Week 20
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
Study Arms (3)
2 mg perampanel
EXPERIMENTALThe 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
EXPERIMENTALThe 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.
placebo
PLACEBO COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients with idiopathic Parkinson's Disease fulfilling the United Kingdom (UK) Parkinson's disease Society Brain Bank diagnostic criteria 7, with a good response to levodopa.
- Patients must have been diagnosed with idiopathic PD at \> 30 years of age.
- Patients must have predictable motor fluctuations of the wearing "OFF" type.
- Patients must rate between II-IV on the Hoehn \& Yahr scale when in an "OFF" state.
- Patients must be taking optimized levodopa therapy.
You may not qualify if:
- Pregnant or lactating women.
- Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (eg, abstinence, intrauterine device or barrier method plus hormonal method). These patients must have a negative serum beta-human chorionic gonadotrophin (B-HCG) test at the Screening visit, and a negative urine pregnancy test at the Baseline visit (Day 0). These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrheic for at least one year to be considered of non-child bearing potential as determined by the Investigator.
- Patients with a past or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual - 4th edition (DSM IV) criteria.
- Patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
- Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, hematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (114)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
North Alabama Neuroscience Research Associates
Huntsville, Alabama, 35801, United States
Pivotal Research Centers
Peoria, Arizona, 85381, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, 85741-3537, United States
Clinical Trials Inc.
Little Rock, Arkansas, 72205, United States
UAMS Department of Neurology
Little Rock, Arkansas, 72205, United States
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, 92708, United States
Margolin Brain Institute
Fresno, California, 93720, United States
University of California Medical Center - Irvine
Irvine, California, 92697, United States
Coastal Neurological Group
La Jolla, California, 92037, United States
Scripps Clinic
La Jolla, California, 92037, United States
University of California at San Diego - Department of Neurology
La Jolla, California, 92161, United States
Loma Linda University
Loma Linda, California, 92354, United States
University of Southern California
Los Angeles, California, 90033, United States
Pacific Neuroscience Medical Group, Inc.
Oxnard, California, 93030, United States
University of California San Francisco Medical Center
San Francisco, California, 94143-1969, United States
The Parkinson's Institute
Sunnyvale, California, 94089, United States
Mile High Research Center
Denver, Colorado, 80218, United States
University Of Colorado
Denver, Colorado, 80262, United States
Colorado Neurology
Englewood, Colorado, 80113, United States
Associated Neurologists, PC - Danbury
Danbury, Connecticut, 06810, United States
Hartford Hospital
Hartford, Connecticut, 06106, United States
Molecular Neuroimaging, LLC
New Haven, Connecticut, 06511, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007-2197, United States
Parkinson's Disease and Movement Disorder Center of Boca Raton
Boca Raton, Florida, 33486, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
University of Florida
Gainesville, Florida, 32610, United States
Sunrise Clinical Research
Hollywood, Florida, 33021, United States
University of Florida - Department of Neurology
Jacksonville, Florida, 32209, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
University of Miami
Miami, Florida, 33136, United States
Miami Research Associates
Miami, Florida, 33173, United States
Palm Beach Neurological Center
Palm Beach Gardens, Florida, 33418, United States
Gil, Ramon A.
Port Charlotte, Florida, 33952, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33701, United States
University Of South Florida Movement Disorders Clinic
Tampa, Florida, 33606, United States
Cleveland Clinic Florida - Weston
Weston, Florida, 33331, United States
Emory University
Atlanta, Georgia, 30329, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Dekalb Neurology Associates, LLC/DNA Research
Decatur, Georgia, 30033, United States
Northwestern University Medical School
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46805, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University Of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas
Kansas City, Kansas, 66160, United States
University Of Kentucky
Lexington, Kentucky, 40536-0284, United States
Kentucky Neuroscience Research
Louisville, Kentucky, 40202, United States
LSUHSC-Shreveport
Shreveport, Louisiana, 71103, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Parkinson's and Movement Disorders Center of Maryland
Elkridge, Maryland, 21075, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Harvard Vanguard Medical Associates
Boston, Massachusetts, 02215, United States
Quest Research Institute
Bingham Farms, Michigan, 48025, United States
The Clinical Neurosciences Center
Southfield, Michigan, 48034, United States
Northern Michigan Neurology
Traverse City, Michigan, 49684, United States
Struthers Parkinson's Center
Golden Valley, Minnesota, 55427, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University
St Louis, Missouri, 63110, United States
Creighton University - Department of Neurology
Omaha, Nebraska, 68131, United States
University of Nevada School of Medicine
Las Vegas, Nevada, 89102, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, 08901, United States
Albany Medical College
Albany, New York, 12205, United States
Parkinson's Disease and Movement Disorder Center of Long Island
Commack, New York, 11725, United States
New York University Medical Center
Forest Hills, New York, 11375, United States
North Shore Medical Center
Manhasset, New York, 11030, United States
The Mount Sinai Medical Center
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Columbia University
New York, New York, 10032, United States
University of Rochester - Neurology Clinic
Rochester, New York, 14618, United States
Asheville Neurology Specialists. PA
Asheville, North Carolina, 28806, United States
Asheville Neurology Specialists
Asheville, North Carolina, 28806, United States
Duke University
Durham, North Carolina, 27705, United States
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, 27607-6520, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Neurology Specialists, Inc.
Dayton, Ohio, 45408, United States
The University of Toledo College of Medicine
Toledo, Ohio, 43614, United States
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Crozer Medical Center
Upland, Pennsylvania, 19013, United States
Lankenau Hospital
Wynnewood, Pennsylvania, 19096-3425, United States
Semmes Murphey Neurology and Spine Institute
Memphis, Tennessee, 38103, United States
Radiant Research - Dallas North
Dallas, Texas, 75231, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Agape' Medical Center, Inc.
Lubbock, Texas, 79410, United States
Bhupesh Dihenia, MD, PA
Lubbock, Texas, 79410, United States
Neurology Associates
San Antonio, Texas, 78258, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Hunter Holmes McGuire
Richmond, Virginia, 23249, United States
Neurology and Neurosurgery Associates of Tacoma, PLLC
Tacoma, Washington, 98405, United States
Capitol Neurology
Charleston, West Virginia, 25301, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Wisconsin Institute for Neurologic and Sleep Disorders
Milwaukee, Wisconsin, 53233, United States
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
University of Alberta
Edmonton, Alberta, T5G 0B7, Canada
Pacific Parkinson Research Centre
Vancouver, British Columbia, V6T 2B5, Canada
Saint John Regional Hospital, 5DN
Saint John, New Brunswick, E2L 4L2, Canada
David King, MD
Halifax, Nova Scotia, B3J 3T1, Canada
Centre For Movement Disorders
Markham, Ontario, L6B 1C9, Canada
Parkinson's and Neurodegenerative Disorders Clinic
Ottawa, Ontario, K1G 4G3, Canada
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y 4E9, Canada
Torotnto Western Hospital-University Health Network
Toronto, Ontario, M5T 2S8, Canada
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, J4V 2J2, Canada
CHUM- Hotel-Dieu
Montreal, Quebec, H2W 1T8, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
SMBD Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Quebec Memory and Motor Skills Disorders Clinic
Québec, Quebec, G1R 3X5, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eisai Inc.
- Organization
- Eisai Call Center
Study Officials
- STUDY DIRECTOR
David Squillacote, M.D.
Eisai Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2006
First Posted
August 24, 2006
Study Start
August 1, 2006
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
May 20, 2013
Results First Posted
February 5, 2013
Record last verified: 2013-01