Clinical trial NCT00036218: Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.
Official title: A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-09
Enrollment: 600
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: The primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

Parkinson's disease of less than 7 years duration

Modified Hoehn and Yahr Scale Stages 1 through 3.

Age greater than or equal to 30 years old.

Men or women (women of childbearing potential must have a negative pregnancy test at screen) and both must use adequate contraceptive methods.

Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Atypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.

Levodopa received for 1-year accumulated interval in the last two years.

Dopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days prior to baseline.

Unstable dose regimes of hypnotics, anxiolytics or antidepressants

Dementia

History of stereotaxic brain surgery, psychosis or active epilepsy within past year.

Participation in clinical trial within the previous 30 days.

Malignant melanoma or history of melanoma

Significant medical or pshychiatric condition.

Primary outcomes:
measure: Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo
Secondary outcomes:
measure: To assess the safety profile of sumanirole; the benefit of sumanirole in quality of life measures, and change from baseline in UPDRS II + III total scores at end of maintenance, for sumanirole compared to ropinirole
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Carmichael
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Irvine
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: Loma Linda
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Oceanside
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: San Luis Obiapo
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Fairfield
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Wilmington
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Maitland
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Naples
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Beach Gardens
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Conyers
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Glenbrook
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lake Charles
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Frederick
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Rockville
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: East Lansing
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Grand Rapids
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Southfield
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Traverse City
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Golden Valley
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: St. Cloud
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Morristown
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New Brunswick
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Ridgewood
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Manhasset
country: United States
facility: Pfizer Investigational Site
state: New York
city: Mineola
country: United States
facility: Pfizer Investigational Site
state: New York
city: Mount Vernon
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Asheville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Norristown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Upland
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Bellevue
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Wenatchee
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Mar Del Plata
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Mexico City
country: Mexico
facility: Pfizer Investigational Site
state: Mexico D.F.
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Carolina
country: Puerto Rico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: