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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.

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00036218
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Drug: sumanirole
Drug: ropinirole
Phase III

Genetics Home Reference related topics:   familial paroxysmal nonkinesigenic dyskinesia    Parkinson disease   

MedlinePlus related topics:   Parkinson's Disease   

ChemIDplus related topics:   Ropinirole    Ropinirole hydrochloride    Sumanirole   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

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; 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

Estimated Enrollment:   600
Study Start Date:   December 2001
Estimated Study Completion Date:   April 2003

  Eligibility
Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036218

Show 103 study locations  Show 103 Study Locations

Sponsors and Collaborators
Pfizer

Investigators
Study Director:     Pfizer CT.gov Call Center     Pfizer    
  More Information


To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   666E-CNS-0075-021
First Received:   May 8, 2002
Last Updated:   June 6, 2006
ClinicalTrials.gov Identifier:   NCT00036218
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Signs and Symptoms
Ropinirole
Dopamine
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Antiparkinson Agents
Dopamine Agents
Dopamine Agonists
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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