Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease
- Conditions
- Parkinson Disease
- Registration Number
- NCT00058838
- Lead Sponsor
- Pfizer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 854
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇪🇸Zaragoza, Spain