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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 15, 2003
Last Update Posted: June 7, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The primary purpose of this study is to determine whether sumanirole, at three different dose levels, is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease

Condition Intervention Phase
Parkinson Disease Drug: sumanirole Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo

Estimated Enrollment: 854
Study Start Date: April 2003
Estimated Study Completion Date: September 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Idiopathic Parkinson's disease < 7 years duration

Modified Hoehn and Yahr Scale Stages I through III

Age greater than or equal to 30 years old

Patients or their partners must use adequate contraceptive methods

Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and do not plan on traveling extensively during the study

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


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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00058838

  Show 135 Study Locations
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00058838     History of Changes
Other Study ID Numbers: DA2APD-0075-031
First Submitted: April 14, 2003
First Posted: April 15, 2003
Last Update Posted: June 7, 2006
Last Verified: June 2006

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases