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| Descriptive Information Fields | |||||
| Brief Title † | Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease | ||||
| 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. | ||||
| 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 |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | 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 Measure † | To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo | ||||
| Condition † | Parkinson Disease | ||||
| Intervention † | Drug: sumanirole | ||||
| MEDLINE PMIDs | |||||
| Links | To obtain contact information for a study center near you, click here.  |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 854 | ||||
| Start Date † | April 2003 | ||||
| Completion Date | September 2004 | ||||
| Eligibility Criteria † | 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 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 |
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| Gender | Both | ||||
| Ages | 30 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Argentina, Australia, Austria, Belgium, Colombia, France, Germany, Greece, Italy, Mexico, Peru, Puerto Rico, Spain | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00058838 | ||||
| Organization ID | DA2APD-0075-031 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Pfizer | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Pfizer | ||||
| Verification Date | June 2006 | ||||
| First Received Date † | April 14, 2003 | ||||
| Last Updated Date | June 6, 2006 | ||||
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