NCT00058838
Completed
Phase 3
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.
ConditionsParkinson Disease
Drugssumanirole
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 854
- Locations
- 1
- Primary Endpoint
- Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo
Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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 Outcomes
- To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo
Investigators
Study Sites (1)
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