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Parkinson's DiseasePhase 3NCT00368108

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

A Phase 3 study testing 2 mg perampanel and 4 mg perampanel in people with Parkinson's Disease, run by Eisai Inc. at 114 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
2 mg perampanel and 4 mg perampanel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
752 participants
Where
114 sitesin 2 countries
Study dates
Aug 2006to Jan 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

114 sites in 2 countries.

114 sites in 2 countries

United States99 sites

  • Albany Medical College

    Albany, New York, 12205

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Asheville Neurology Specialists. PA

    Asheville, North Carolina, 28806

  • Asheville Neurology Specialists

    Asheville, North Carolina, 28806

  • Emory University

    Atlanta, Georgia, 30329

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Quest Research Institute

    Bingham Farms, Michigan, 48025

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Parkinson's Disease and Movement Disorder Center of Boca Raton

    Boca Raton, Florida, 33486

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Harvard Vanguard Medical Associates

    Boston, Massachusetts, 02215

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Capitol Neurology

    Charleston, West Virginia, 25301

  • Northwestern University Medical School

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Parkinson's Disease and Movement Disorder Center of Long Island

    Commack, New York, 11725

  • Radiant Research - Dallas North

    Dallas, Texas, 75231

  • Associated Neurologists, PC - Danbury

    Danbury, Connecticut, 06810

  • Neurology Specialists, Inc.

    Dayton, Ohio, 45408

  • Dekalb Neurology Associates, LLC/DNA Research

    Decatur, Georgia, 30033

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Mile High Research Center

    Denver, Colorado, 80218

  • University Of Colorado

    Denver, Colorado, 80262

  • Duke University

    Durham, North Carolina, 27705

  • Parkinson's and Movement Disorders Center of Maryland

    Elkridge, Maryland, 21075

  • Colorado Neurology

    Englewood, Colorado, 80113

  • New York University Medical Center

    Forest Hills, New York, 11375

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46805

  • The Parkinson's and Movement Disorder Institute

    Fountain Valley, California, 92708

  • Margolin Brain Institute

    Fresno, California, 93720

  • University of Florida

    Gainesville, Florida, 32610

  • Struthers Parkinson's Center

    Golden Valley, Minnesota, 55427

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • Sunrise Clinical Research

    Hollywood, Florida, 33021

  • Baylor College of Medicine

    Houston, Texas, 77030

  • North Alabama Neuroscience Research Associates

    Huntsville, Alabama, 35801

  • Indiana University

    Indianapolis, Indiana, 46202

  • University Of Iowa

    Iowa City, Iowa, 52242

  • University of California Medical Center - Irvine

    Irvine, California, 92697

  • University of Florida - Department of Neurology

    Jacksonville, Florida, 32209

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • University of Kansas

    Kansas City, Kansas, 66160

  • Coastal Neurological Group

    La Jolla, California, 92037

  • Scripps Clinic

    La Jolla, California, 92037

  • University of California at San Diego - Department of Neurology

    La Jolla, California, 92161

  • University of Nevada School of Medicine

    Las Vegas, Nevada, 89102

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University Of Kentucky

    Lexington, Kentucky, 40536-0284

  • Clinical Trials Inc.

    Little Rock, Arkansas, 72205

  • UAMS Department of Neurology

    Little Rock, Arkansas, 72205

  • Loma Linda University

    Loma Linda, California, 92354

  • University of Southern California

    Los Angeles, California, 90033

  • Kentucky Neuroscience Research

    Louisville, Kentucky, 40202

  • Agape' Medical Center, Inc.

    Lubbock, Texas, 79410

  • Bhupesh Dihenia, MD, PA

    Lubbock, Texas, 79410

  • North Shore Medical Center

    Manhasset, New York, 11030

  • Semmes Murphey Neurology and Spine Institute

    Memphis, Tennessee, 38103

  • University of Miami

    Miami, Florida, 33136

  • Miami Research Associates

    Miami, Florida, 33173

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Wisconsin Institute for Neurologic and Sleep Disorders

    Milwaukee, Wisconsin, 53233

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • University of Medicine and Dentistry of New Jersey

    New Brunswick, New Jersey, 08901

  • Molecular Neuroimaging, LLC

    New Haven, Connecticut, 06511

  • The Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Columbia University

    New York, New York, 10032

  • University of Oklahoma - Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Creighton University - Department of Neurology

    Omaha, Nebraska, 68131

  • Pacific Neuroscience Medical Group, Inc.

    Oxnard, California, 93030

  • Palm Beach Neurological Center

    Palm Beach Gardens, Florida, 33418

  • Pivotal Research Centers

    Peoria, Arizona, 85381

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Gil, Ramon A.

    Port Charlotte, Florida, 33952

  • Raleigh Neurology Associates, P.A.

    Raleigh, North Carolina, 27607-6520

  • Hunter Holmes McGuire

    Richmond, Virginia, 23249

  • University of Rochester - Neurology Clinic

    Rochester, New York, 14618

  • Neurology Associates

    San Antonio, Texas, 78258

  • University of California San Francisco Medical Center

    San Francisco, California, 94143-1969

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • LSUHSC-Shreveport

    Shreveport, Louisiana, 71103

  • The Clinical Neurosciences Center

    Southfield, Michigan, 48034

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Washington University

    St Louis, Missouri, 63110

  • Suncoast Neuroscience Associates, Inc.

    St. Petersburg, Florida, 33701

  • The Parkinson's Institute

    Sunnyvale, California, 94089

  • Neurology and Neurosurgery Associates of Tacoma, PLLC

    Tacoma, Washington, 98405

  • University Of South Florida Movement Disorders Clinic

    Tampa, Florida, 33606

  • The University of Toledo College of Medicine

    Toledo, Ohio, 43614

  • Northern Michigan Neurology

    Traverse City, Michigan, 49684

  • Northwest NeuroSpecialists, PLLC

    Tucson, Arizona, 85741-3537

  • Crozer Medical Center

    Upland, Pennsylvania, 19013

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007-2197

  • Cleveland Clinic Florida - Weston

    Weston, Florida, 33331

  • Lankenau Hospital

    Wynnewood, Pennsylvania, 19096-3425

Other trials in United States

Canada15 sites

  • University of Calgary

    Calgary, Alberta, T2N 4N1

  • University of Alberta

    Edmonton, Alberta, T5G 0B7

  • Clinique Neuro Rive-Sud

    Greenfield Park, Quebec, J4V 2J2

  • David King, MD

    Halifax, Nova Scotia, B3J 3T1

  • Centre For Movement Disorders

    Markham, Ontario, L6B 1C9

  • CHUM- Hotel-Dieu

    Montreal, Quebec, H2W 1T8

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • SMBD Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Parkinson's and Neurodegenerative Disorders Clinic

    Ottawa, Ontario, K1G 4G3

  • The Ottawa Hospital - Civic Campus

    Ottawa, Ontario, K1Y 4E9

  • Quebec Memory and Motor Skills Disorders Clinic

    Québec, Quebec, G1R 3X5

  • Saint John Regional Hospital, 5DN

    Saint John, New Brunswick, E2L 4L2

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Torotnto Western Hospital-University Health Network

    Toronto, Ontario, M5T 2S8

  • Pacific Parkinson Research Centre

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

About this study

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

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.

Being tested
2 mg perampanel, 4 mg perampanel, placebo comparator
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2 mg perampanelDrug

    2 mg perampanel

  • 4 mg perampanelDrug

    4 mg perampanel

  • placebo comparatorDrug

    placebo comparator

Study groups in NCT00368108
Study groupRoleWhat they receive
2 mg perampanelExperimentalThe 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.
Receives: Drug: 2 mg perampanel
4 mg perampanelExperimentalThe 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.
Receives: Drug: 4 mg perampanel
placeboPlacebo 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.
Receives: Drug: placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 20

Secondary outcomes (3)

  1. Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data)

    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.

    Measured: Baseline and Week 20

  2. Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data)

    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.

    Measured: Baseline and Week 20

  3. Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data)

    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.

    Measured: Baseline and Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
752 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00368108
Sponsor's protocol ID
E2007-A001-302
Status last verified
Jan 2013
First submitted
22 Aug 2006
Last updated
20 May 2013

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 2 mg perampanel and 4 mg perampanel in people with Parkinson's Disease, run by Eisai Inc. at 114 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00368108.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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