Clinical trial NCT00036205: Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease
Official title: Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Parkinson Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-05-09
Enrollment: 984
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: 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).
measure: Part II -- Activities of Daily Living, will be collected in order to record the patient's level of function between visits.
measure: Part III will be used to evaluate motor function.
measure: 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.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Concord
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 Diego
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: Sunnyvale
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: Englewood
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Fairfield
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Hartford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Trumbull
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: 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: Sarasota
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: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Marietta
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: Elkhart
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Dubuque
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lenexa
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Crestview Hills
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Covington
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Lake Charles
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Scarborough
country: United States
facility: Pfizer Investigational Site
state: Maine
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Elkridge
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Frederick
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Bingham Farms
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Farmington Hills
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Grand Rapids
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Royal Oak
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Traverse City
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Fridley
country: United States
facility: Pfizer Investigational Site
state: Minnesota
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: Lee's Summit
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Salisbury
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: Las Vegas
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: 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: Rochester
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: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Canfield
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
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: 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: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Bellevue
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Wenatchee
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Marshfield
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Barcelona
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
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: D.c.
city: Carolina
country: Puerto Rico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: