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

May 13, 2013 updated by: Eisai Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

752

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline and Week 20
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
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.
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)
Time Frame: 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.
Baseline and Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Study Director: David Squillacote, M.D., Eisai Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

August 22, 2006

First Submitted That Met QC Criteria

August 22, 2006

First Posted (Estimate)

August 24, 2006

Study Record Updates

Last Update Posted (Estimate)

May 20, 2013

Last Update Submitted That Met QC Criteria

May 13, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2007-A001-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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