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| 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 |
| Drug Information available for: | Ropinirole Ropinirole hydrochloride Sumanirole |
| 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. |
| 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 |
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![]() |
Show 103 Study Locations |
| Pfizer |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
To obtain contact information for a study center near you, click here. 
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| 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 |
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