CClinicalTrials.gg
TerminatedNCT00036205Updated Jan 18, 2007

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

A Phase 3 interventional study of sumanirole in Parkinson Disease, sponsored by Pfizer. Terminated at 110 sites in 4 countries. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2007-01-18.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
984
Allocation
Non-randomized
Ages
30 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.

This study's enrollment of 984 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
984 participants

Interventions

  • Drugsumanirole
06

What researchers measure

Primary outcomes

  1. 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

  1. 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).

  2. Part II -- Activities of Daily Living, will be collected in order to record the patient's level of function between visits.

  3. Part III will be used to evaluate motor function.

  4. 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.

07

Study locations

110 sites
  • Pfizer Investigational Site
    Birmingham, Alabama, United States
  • Pfizer Investigational Site
    Peoria, Arizona, United States
  • Pfizer Investigational Site
    Tucson, Arizona, United States
  • Pfizer Investigational Site
    Little Rock, Arkansas, United States
  • Pfizer Investigational Site
    Concord, California, United States
  • Pfizer Investigational Site
    Fresno, California, United States
  • Pfizer Investigational Site
    Irvine, California, United States
  • Pfizer Investigational Site
    La Jolla, California, United States
  • Pfizer Investigational Site
    Loma Linda, California, United States
  • Pfizer Investigational Site
    Los Angeles, California, United States
  • Pfizer Investigational Site
    Oceanside, California, 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
    Sunnyvale, California, United States
  • Pfizer Investigational Site
    Walnut Creek, California, United States
  • Pfizer Investigational Site
    Denver, Colorado, United States
  • Pfizer Investigational Site
    Englewood, Colorado, United States
  • Pfizer Investigational Site
    Fairfield, Connecticut, United States
  • Pfizer Investigational Site
    Hartford, Connecticut, United States
  • Pfizer Investigational Site
    New Haven, Connecticut, United States
  • Pfizer Investigational Site
    Trumbull, Connecticut, United States
  • Pfizer Investigational Site
    Wilmington, Delaware, United States
  • Pfizer Investigational Site
    Boca Raton, Florida, United States
  • Pfizer Investigational Site
    Clearwater, Florida, United States
  • Pfizer Investigational Site
    Fort Lauderdale, Florida, United States
  • Pfizer Investigational Site
    Jacksonville, Florida, United States
  • Pfizer Investigational Site
    Maitland, Florida, United States
  • Pfizer Investigational Site
    Miami, Florida, United States
  • Pfizer Investigational Site
    Naples, Florida, 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
    Sarasota, Florida, United States
  • Pfizer Investigational Site
    St Petersburg, Florida, United States
  • Pfizer Investigational Site
    Tallahassee, Florida, United States
  • Pfizer Investigational Site
    Tampa, Florida, United States
  • Pfizer Investigational Site
    Atlanta, Georgia, United States
  • Pfizer Investigational Site
    Decatur, Georgia, United States
  • Pfizer Investigational Site
    Marietta, Georgia, United States
  • Pfizer Investigational Site
    Savannah, Georgia, United States
  • Pfizer Investigational Site
    Chicago, Illinois, United States
  • Pfizer Investigational Site
    Elkhart, Indiana, United States
  • Pfizer Investigational Site
    Des Moines, Iowa, United States
  • Pfizer Investigational Site
    Dubuque, Iowa, United States
  • Pfizer Investigational Site
    Kansas City, Kansas, United States
  • Pfizer Investigational Site
    Lenexa, Kansas, United States
  • Pfizer Investigational Site
    Crestview Hills, Kentucky, United States
  • Pfizer Investigational Site
    Covington, Louisiana, United States
  • Pfizer Investigational Site
    Lake Charles, Louisiana, United States
  • Pfizer Investigational Site
    Scarborough, Maine, United States
  • Pfizer Investigational Site
    Baltimore, Maryland, United States
  • Pfizer Investigational Site
    Elkridge, Maryland, United States
  • Pfizer Investigational Site
    Frederick, Maryland, United States
  • Pfizer Investigational Site
    Boston, Massachusetts, United States
  • Pfizer Investigational Site
    Bingham Farms, Michigan, United States
  • Pfizer Investigational Site
    Farmington Hills, Michigan, United States
  • Pfizer Investigational Site
    Grand Rapids, Michigan, United States
  • Pfizer Investigational Site
    Royal Oak, Michigan, United States
  • Pfizer Investigational Site
    Traverse City, Michigan, United States
  • Pfizer Investigational Site
    Fridley, Minnesota, United States
  • Pfizer Investigational Site
    Golden Valley, Minnesota, United States
  • Pfizer Investigational Site
    Minneapolis, Minnesota, United States
  • Pfizer Investigational Site
    St. Cloud, Minnesota, United States
  • Pfizer Investigational Site
    Lee's Summit, Missouri, United States
  • Pfizer Investigational Site
    Salisbury, Missouri, United States
  • Pfizer Investigational Site
    Springfield, Missouri, United States
  • Pfizer Investigational Site
    Omaha, Nebraska, United States
  • Pfizer Investigational Site
    Las Vegas, Nevada, United States
  • Pfizer Investigational Site
    Lebanon, New Hampshire, United States
  • Pfizer Investigational Site
    Morristown, New Jersey, United States
  • Pfizer Investigational Site
    New Brunswick, New Jersey, United States
  • Pfizer Investigational Site
    Manhasset, New York, United States
  • Pfizer Investigational Site
    Mineola, New York, United States
  • Pfizer Investigational Site
    Mount Vernon, New York, United States
  • Pfizer Investigational Site
    New York, New York, United States
  • Pfizer Investigational Site
    Rochester, New York, United States
  • Pfizer Investigational Site
    Syracuse, New York, United States
  • Pfizer Investigational Site
    Asheville, North Carolina, United States
  • Pfizer Investigational Site
    Charlotte, North Carolina, United States
  • Pfizer Investigational Site
    Raleigh, North Carolina, United States
  • Pfizer Investigational Site
    Winston-Salem, North Carolina, United States
  • Pfizer Investigational Site
    Canfield, Ohio, United States
  • Pfizer Investigational Site
    Dayton, Ohio, United States
  • Pfizer Investigational Site
    Oklahoma City, Oklahoma, United States
  • Pfizer Investigational Site
    Eugene, Oregon, United States
  • Pfizer Investigational Site
    Norristown, Pennsylvania, United States
  • Pfizer Investigational Site
    Sellersville, Pennsylvania, United States
  • Pfizer Investigational Site
    Upland, Pennsylvania, United States
  • Pfizer Investigational Site
    Knoxville, Tennessee, United States
  • Pfizer Investigational Site
    Memphis, Tennessee, United States
  • Pfizer Investigational Site
    Austin, Texas, United States
  • Pfizer Investigational Site
    Dallas, Texas, United States
  • Pfizer Investigational Site
    Houston, Texas, United States
  • Pfizer Investigational Site
    San Antonio, Texas, United States
  • Pfizer Investigational Site
    Salt Lake City, Utah, United States
  • Pfizer Investigational Site
    Burlington, Vermont, United States
  • Pfizer Investigational Site
    Charlottesville, Virginia, United States
  • Pfizer Investigational Site
    Richmond, Virginia, United States
  • Pfizer Investigational Site
    Bellevue, Washington, United States

Showing the first 100 of 110 sites across 4 countries.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00036205
Lead sponsor
Pfizer
First posted
May 9, 2002
Start date
Aug 2000
Completion
Dec 2004
Last update
Jan 18, 2007

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.

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