Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.

Parkinson Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036218
• Other study ID #: 666E-CNS-0075-021
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2002
• Last updated: June 6, 2006
• Start date: December 2001
• Est. completion date: April 2003

Study information

• Verified date: June 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• sumanirole

• ropinirole

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires	Capital Federal
Argentina	Pfizer Investigational Site	Buenos Aires	Capital Federal
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Mar Del Plata	Buenos Aires
Mexico	Pfizer Investigational Site	Mexico City	Mexico D.F.
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon
Puerto Rico	Pfizer Investigational Site	Carolina
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Asheville	North Carolina
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bellevue	Washington
United States	Pfizer Investigational Site	Boca Raton	Florida
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Burlington	Vermont
United States	Pfizer Investigational Site	Carmichael	California
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Columbia	Maryland
United States	Pfizer Investigational Site	Conyers	Georgia
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	East Lansing	Michigan
United States	Pfizer Investigational Site	Fairfield	Connecticut
United States	Pfizer Investigational Site	Fort Lauderdale	Florida
United States	Pfizer Investigational Site	Frederick	Maryland
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Glenbrook	Illinois
United States	Pfizer Investigational Site	Golden Valley	Minnesota
United States	Pfizer Investigational Site	Grand Rapids	Michigan
United States	Pfizer Investigational Site	Henderson	Nevada
United States	Pfizer Investigational Site	Hot Springs	Arkansas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Irvine	California
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Kansas City	Kansas
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	Lake Charles	Louisiana
United States	Pfizer Investigational Site	Lebanon	New Hampshire
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Loma Linda	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Maitland	Florida
United States	Pfizer Investigational Site	Manhasset	New York
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	Mineola	New York
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Morristown	New Jersey
United States	Pfizer Investigational Site	Mount Vernon	New York
United States	Pfizer Investigational Site	Naples	Florida
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New Brunswick	New Jersey
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Norristown	Pennsylvania
United States	Pfizer Investigational Site	Oceanside	California
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Palm Beach Gardens	Florida
United States	Pfizer Investigational Site	Plantation	Florida
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Ridgewood	New Jersey
United States	Pfizer Investigational Site	Rockville	Maryland
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	San Luis Obiapo	California
United States	Pfizer Investigational Site	Savannah	Georgia
United States	Pfizer Investigational Site	Sellersville	Pennsylvania
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Southfield	Michigan
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Springfield	Missouri
United States	Pfizer Investigational Site	St. Cloud	Minnesota
United States	Pfizer Investigational Site	St. Petersburg	Florida
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Tallahassee	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Traverse City	Michigan
United States	Pfizer Investigational Site	Upland	Pennsylvania
United States	Pfizer Investigational Site	Walnut Creek	California
United States	Pfizer Investigational Site	Walnut Creek	California
United States	Pfizer Investigational Site	Wenatchee	Washington
United States	Pfizer Investigational Site	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   To obtain contact information for a study center near you, click here.