Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00368108
First received: August 22, 2006
Last updated: May 13, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: 2 mg perampanel
Drug: 4 mg perampanel
Drug: placebo comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data) [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
    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:
  • Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data) [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and Week 20 ] [ Designated as safety issue: No ]
    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.


Enrollment: 752
Study Start Date: August 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 2 mg perampanel
2 mg perampanel
Experimental: 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.
Drug: 4 mg perampanel
4 mg perampanel
Placebo Comparator: placebo
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.
Drug: placebo comparator
placebo comparator

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  1. 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.
  2. Patients must have been diagnosed with idiopathic PD at > 30 years of age.
  3. Patients must have predictable motor fluctuations of the wearing "OFF" type.
  4. Patients must rate between II-IV on the Hoehn & Yahr scale when in an "OFF" state.
  5. Patients must be taking optimized levodopa therapy.

EXCLUSION CRITERIA:

  1. Pregnant or lactating women.
  2. 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.
  3. Patients with a past or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual - 4th edition (DSM IV) criteria.
  4. Patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
  5. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368108

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
North Alabama Neuroscience Research Associates
Huntsville, Alabama, United States, 35801
United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Northwest NeuroSpecialists, PLLC
Tucson, Arizona, United States, 85741-3537
United States, Arkansas
UAMS Department of Neurology
Little Rock, Arkansas, United States, 72205
Clinical Trials Inc.
Little Rock, Arkansas, United States, 72205
United States, California
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
Margolin Brain Institute
Fresno, California, United States, 93720
University of California Medical Center - Irvine
Irvine, California, United States, 92697
University of California at San Diego - Department of Neurology
La Jolla, California, United States, 92161
Coastal Neurological Group
La Jolla, California, United States, 92037
Scripps Clinic
La Jolla, California, United States, 92037
Loma Linda University
Loma Linda, California, United States, 92354
University of Southern California
Los Angeles, California, United States, 90033
Pacific Neuroscience Medical Group, Inc.
Oxnard, California, United States, 93030
University of California San Francisco Medical Center
San Francisco, California, United States, 94143-1969
The Parkinson's Institute
Sunnyvale, California, United States, 94089
United States, Colorado
Mile High Research Center
Denver, Colorado, United States, 80218
University Of Colorado
Denver, Colorado, United States, 80262
Colorado Neurology
Englewood, Colorado, United States, 80113
United States, Connecticut
Associated Neurologists, PC - Danbury
Danbury, Connecticut, United States, 06810
Hartford Hospital
Hartford, Connecticut, United States, 06106
Molecular Neuroimaging, LLC
New Haven, Connecticut, United States, 06511
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007-2197
United States, Florida
Parkinson's Disease and Movement Disorder Center of Boca Raton
Boca Raton, Florida, United States, 33486
Brain Matters Research
Delray Beach, Florida, United States, 33445
University of Florida
Gainesville, Florida, United States, 32610
Sunrise Clinical Research
Hollywood, Florida, United States, 33021
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
University of Florida - Department of Neurology
Jacksonville, Florida, United States, 32209
Miami Research Associates
Miami, Florida, United States, 33173
University of Miami
Miami, Florida, United States, 33136
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States, 33418
Gil, Ramon A.
Port Charlotte, Florida, United States, 33952
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States, 33701
University Of South Florida Movement Disorders Clinic
Tampa, Florida, United States, 33606
Cleveland Clinic Florida - Weston
Weston, Florida, United States, 33331
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
Medical College of Georgia
Augusta, Georgia, United States, 30912
Dekalb Neurology Associates, LLC/DNA Research
Decatur, Georgia, United States, 30033
United States, Illinois
Northwestern University Medical School
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
United States, Indiana
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States, 46805
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University Of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
University Of Kentucky
Lexington, Kentucky, United States, 40536-0284
Kentucky Neuroscience Research
Louisville, Kentucky, United States, 40202
United States, Louisiana
LSUHSC-Shreveport
Shreveport, Louisiana, United States, 71103
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Parkinson's and Movement Disorders Center of Maryland
Elkridge, Maryland, United States, 21075
United States, Massachusetts
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States, 02215
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
The Clinical Neurosciences Center
Southfield, Michigan, United States, 48034
Northern Michigan Neurology
Traverse City, Michigan, United States, 49684
United States, Minnesota
Struthers Parkinson's Center
Golden Valley, Minnesota, United States, 55427
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Nebraska
Creighton University - Department of Neurology
Omaha, Nebraska, United States, 68131
United States, Nevada
University of Nevada School of Medicine
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Albany Medical College
Albany, New York, United States, 12205
Parkinson's Disease and Movement Disorder Center of Long Island
Commack, New York, United States, 11725
New York University Medical Center
Forest Hills, New York, United States, 11375
North Shore Medical Center
Manhasset, New York, United States, 11030
Columbia University Medical Center
New York, New York, United States, 10032
Columbia University
New York, New York, United States, 10032
The Mount Sinai Medical Center
New York, New York, United States, 10029
University of Rochester - Neurology Clinic
Rochester, New York, United States, 14618
United States, North Carolina
Asheville Neurology Specialists
Asheville, North Carolina, United States, 28806
Asheville Neurology Specialists. PA
Asheville, North Carolina, United States, 28806
Duke University
Durham, North Carolina, United States, 27705
Raleigh Neurology Associates, P.A.
Raleigh, North Carolina, United States, 27607-6520
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Neurology Specialists, Inc.
Dayton, Ohio, United States, 45408
The University of Toledo College of Medicine
Toledo, Ohio, United States, 43614
United States, Oklahoma
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Crozer Medical Center
Upland, Pennsylvania, United States, 19013
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096-3425
United States, Tennessee
Semmes Murphey Neurology and Spine Institute
Memphis, Tennessee, United States, 38103
United States, Texas
Radiant Research - Dallas North
Dallas, Texas, United States, 75231
Baylor College of Medicine
Houston, Texas, United States, 77030
Agape' Medical Center, Inc.
Lubbock, Texas, United States, 79410
Bhupesh Dihenia, MD, PA
Lubbock, Texas, United States, 79410
Neurology Associates
San Antonio, Texas, United States, 78258
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
Hunter Holmes McGuire
Richmond, Virginia, United States, 23249
United States, Washington
Neurology and Neurosurgery Associates of Tacoma, PLLC
Tacoma, Washington, United States, 98405
United States, West Virginia
Capitol Neurology
Charleston, West Virginia, United States, 25301
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Wisconsin Institute for Neurologic and Sleep Disorders
Milwaukee, Wisconsin, United States, 53233
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
University of Alberta
Edmonton, Alberta, Canada, T5G 0B7
Canada, British Columbia
Pacific Parkinson Research Centre
Vancouver, British Columbia, Canada, V6T 2B5
Canada, New Brunswick
Saint John Regional Hospital, 5DN
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
David King, MD
Halifax, Nova Scotia, Canada, B3J 3T1
Canada, Ontario
Centre For Movement Disorders
Markham, Ontario, Canada, L6B 1C9
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
Parkinson's and Neurodegenerative Disorders Clinic
Ottawa, Ontario, Canada, K1G 4G3
Torotnto Western Hospital-University Health Network
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada, J4V 2J2
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
SMBD Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
CHUM- Hotel-Dieu
Montreal, Quebec, Canada, H2W 1T8
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Canada
Quebec Memory and Motor Skills Disorders Clinic
Quebec, Canada, G1R 3X5
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: David Squillacote, M.D. Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00368108     History of Changes
Other Study ID Numbers: E2007-A001-302
Study First Received: August 22, 2006
Results First Received: October 23, 2012
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 15, 2014