Clinical trial NCT00368108: Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 752
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Mean Change From Baseline in Total Daily OFF Time (Hours) to Week 20 (Including Last Observation Carried Forward [LOCF] Data)
timeFrame: Baseline and Week 20
Secondary outcomes:
measure: Mean Change From Baseline in Scale UPDRS Part II (ADL) Score in Total Daily OFF Time to Week 20 (Including LOCF Data)
timeFrame: Baseline and Week 20
measure: Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) to Week 20 (Including LOCF Data)
timeFrame: Baseline and Week 20
measure: Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) to Week 20 (Including LOCF Data)
timeFrame: Baseline and Week 20
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: North Alabama Neuroscience Research Associates
state: Alabama
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Tucson
country: United States
facility: Northwest NeuroSpecialists, PLLC
state: Arizona
city: Little Rock
country: United States
facility: Clinical Trials Inc.
state: Arkansas
city: Little Rock
country: United States
facility: UAMS Department of Neurology
state: Arkansas
city: Fountain Valley
country: United States
facility: The Parkinson's and Movement Disorder Institute
state: California
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: Irvine
country: United States
facility: University of California Medical Center - Irvine
state: California
city: La Jolla
country: United States
facility: Coastal Neurological Group
state: California
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: La Jolla
country: United States
facility: University of California at San Diego - Department of Neurology
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Oxnard
country: United States
facility: Pacific Neuroscience Medical Group, Inc.
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Sunnyvale
country: United States
facility: The Parkinson's Institute
state: California
city: Denver
country: United States
facility: Mile High Research Center
state: Colorado
city: Denver
country: United States
facility: University Of Colorado
state: Colorado
city: Englewood
country: United States
facility: Colorado Neurology
state: Colorado
city: Danbury
country: United States
facility: Associated Neurologists, PC - Danbury
state: Connecticut
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Molecular Neuroimaging, LLC
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorder Center of Boca Raton
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hollywood
country: United States
facility: Sunrise Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: University of Florida - Department of Neurology
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Center
state: Florida
city: Port Charlotte
country: United States
facility: Gil, Ramon A.
state: Florida
city: St. Petersburg
country: United States
facility: Suncoast Neuroscience Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: University Of South Florida Movement Disorders Clinic
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida - Weston
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Decatur
country: United States
facility: Dekalb Neurology Associates, LLC/DNA Research
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Medical School
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Iowa City
country: United States
facility: University Of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Lexington
country: United States
facility: University Of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Kentucky Neuroscience Research
state: Kentucky
city: Shreveport
country: United States
facility: LSUHSC-Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Elkridge
country: United States
facility: Parkinson's and Movement Disorders Center of Maryland
state: Maryland
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
city: Bingham Farms
country: United States
facility: Quest Research Institute
state: Michigan
city: Southfield
country: United States
facility: The Clinical Neurosciences Center
state: Michigan
city: Traverse City
country: United States
facility: Northern Michigan Neurology
state: Michigan
city: Golden Valley
country: United States
facility: Struthers Parkinson's Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: Creighton University - Department of Neurology
state: Nebraska
city: Las Vegas
country: United States
facility: University of Nevada School of Medicine
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New Brunswick
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Commack
country: United States
facility: Parkinson's Disease and Movement Disorder Center of Long Island
state: New York
city: Forest Hills
country: United States
facility: New York University Medical Center
state: New York
city: Manhasset
country: United States
facility: North Shore Medical Center
state: New York
city: New York
country: United States
facility: The Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Rochester
country: United States
facility: University of Rochester - Neurology Clinic
state: New York
city: Asheville
country: United States
facility: Asheville Neurology Specialists. PA
state: North Carolina
city: Asheville
country: United States
facility: Asheville Neurology Specialists
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates, P.A.
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Dayton
country: United States
facility: Neurology Specialists, Inc.
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo College of Medicine
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma - Health Sciences Center
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Upland
country: United States
facility: Crozer Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Semmes Murphey Neurology and Spine Institute
state: Tennessee
city: Dallas
country: United States
facility: Radiant Research - Dallas North
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Lubbock
country: United States
facility: Agape' Medical Center, Inc.
state: Texas
city: Lubbock
country: United States
facility: Bhupesh Dihenia, MD, PA
state: Texas
city: San Antonio
country: United States
facility: Neurology Associates
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Richmond
country: United States
facility: Hunter Holmes McGuire
state: Virginia
city: Tacoma
country: United States
facility: Neurology and Neurosurgery Associates of Tacoma, PLLC
state: Washington
city: Charleston
country: United States
facility: Capitol Neurology
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Institute for Neurologic and Sleep Disorders
state: Wisconsin
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Pacific Parkinson Research Centre
state: British Columbia
city: Saint John
country: Canada
facility: Saint John Regional Hospital, 5DN
state: New Brunswick
city: Halifax
country: Canada
facility: David King, MD
state: Nova Scotia
city: Markham
country: Canada
facility: Centre For Movement Disorders
state: Ontario
city: Ottawa
country: Canada
facility: Parkinson's and Neurodegenerative Disorders Clinic
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: Torotnto Western Hospital-University Health Network
state: Ontario
city: Greenfield Park
country: Canada
facility: Clinique Neuro Rive-Sud
state: Quebec
city: Montreal
country: Canada
facility: CHUM- Hotel-Dieu
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Montreal
country: Canada
facility: SMBD Jewish General Hospital
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Quebec
country: Canada
facility: Quebec Memory and Motor Skills Disorders Clinic
Study officials:
affiliation: Eisai Inc.
name: David Squillacote, M.D.
role: STUDY_DIRECTOR
References: