Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00036205
• Other study ID #: M27600011
• Status: Terminated
• Phase: Phase 3
• First received: May 8, 2002
• Last updated: January 17, 2007
• Start date: August 2000
• Est. completion date: December 2004

Study information

• Verified date: January 2007
• 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 objective is to assess the long term safety and tolerability of sumanirole as measured by safety labs, ECG monitoring, vital signs, and adverse event reports in subjects with Parkinson's Disease who participated in previous sumanirole studies.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 984
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Idiopathic Parkinson's disease

• Modified Hoehn and Yahr Scale Stages 1-4

• Age over 30 years

• Previous participation in prior sumanirole studies

Exclusion Criteria:

• Use of dopamine agonist medications and other medications in defined timeframe

• Unstable dose of CNS active therapies (eg, hypnotics, antidepressants, anxiolytics) within the last 30 days

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

• Dementia

• History of active epilepsy within the past year

• Significant liver disease with defined laboratory criteria

• Significant renal disease with defined laboratory criteria

• Certain cardiac conditions

• Electroconvulsive therapy in the previous 90 days

• Subjects participating in other drug studies or receiving other investigational drugs within previous 30 days

• Positive pregnancy test at Screen

• Unwillingness to use adequate contraceptive methods

• Lactating women

• History of stereotaxic brain surgery

• Malignant melanoma or history of treated melanoma

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• sumanirole

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires	Barcelona
Argentina	Pfizer Investigational Site	Buenos Aires	Capital Federal
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Mar Del Plata	Buenos Aires
Colombia	Pfizer Investigational Site	Bogota	D.c.
Colombia	Pfizer Investigational Site	Medellin	Antioquia
Puerto Rico	Pfizer Investigational Site	Carolina
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	Bingham Farms	Michigan
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Boca Raton	Florida
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Burlington	Vermont
United States	Pfizer Investigational Site	Canfield	Ohio
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Charlottesville	Virginia
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Concord	California
United States	Pfizer Investigational Site	Covington	Louisiana
United States	Pfizer Investigational Site	Crestview Hills	Kentucky
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Des Moines	Iowa
United States	Pfizer Investigational Site	Dubuque	Iowa
United States	Pfizer Investigational Site	Elkhart	Indiana
United States	Pfizer Investigational Site	Elkridge	Maryland
United States	Pfizer Investigational Site	Englewood	Colorado
United States	Pfizer Investigational Site	Eugene	Oregon
United States	Pfizer Investigational Site	Fairfield	Connecticut
United States	Pfizer Investigational Site	Farmington Hills	Michigan
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	Fridley	Minnesota
United States	Pfizer Investigational Site	Golden Valley	Minnesota
United States	Pfizer Investigational Site	Grand Rapids	Michigan
United States	Pfizer Investigational Site	Hartford	Connecticut
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	Kansas City	Kansas
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	Las Vegas	Nevada
United States	Pfizer Investigational Site	Lebanon	New Hampshire
United States	Pfizer Investigational Site	Lee's Summit	Missouri
United States	Pfizer Investigational Site	Lenexa	Kansas
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	Marietta	Georgia
United States	Pfizer Investigational Site	Marshfield	Wisconsin
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	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	Norristown	Pennsylvania
United States	Pfizer Investigational Site	Oceanside	California
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
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	Peoria	Arizona
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	Rochester	New York
United States	Pfizer Investigational Site	Royal Oak	Michigan
United States	Pfizer Investigational Site	Salisbury	Missouri
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	San Luis Obiapo	California
United States	Pfizer Investigational Site	Sarasota	Florida
United States	Pfizer Investigational Site	Savannah	Georgia
United States	Pfizer Investigational Site	Scarborough	Maine
United States	Pfizer Investigational Site	Sellersville	Pennsylvania
United States	Pfizer Investigational Site	Springfield	Missouri
United States	Pfizer Investigational Site	St Petersburg	Florida
United States	Pfizer Investigational Site	St. Cloud	Minnesota
United States	Pfizer Investigational Site	Sunnyvale	California
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	Trumbull	Connecticut
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Upland	Pennsylvania
United States	Pfizer Investigational Site	Walnut Creek	California
United States	Pfizer Investigational Site	Wenatchee	Washington
United States	Pfizer Investigational Site	Wilmington	Delaware
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Colombia,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to assess the long term safety and tolerability of sumanirole by measuring Safety labs, ECG monitoring, vital signs and adverse events, over a period of up to 4 years.
Secondary	Pharmacoeconomics, quality of life, and the long term therapeutic response associated with sumanirole by using Parts II and III of the UPDRS (Unified Parkinson’s Disease Rating Scale).
Secondary	Part II -- Activities of Daily Living, will be collected in order to record the patient's level of function between visits.
Secondary	Part III will be used to evaluate motor function.
Secondary	Three quality of life instruments will be employed: a general scale--the Functional Status Questionnaire, a disease specific scale--the Parkinson's Disease Questionnaire, and a utility scale--the EuroQol.

External Links

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