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Tracking Information | |||||
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First Received Date ICMJE | April 14, 2003 | ||||
Last Updated Date | June 6, 2006 | ||||
Start Date ICMJE | April 2003 | ||||
Current Primary Outcome Measures ICMJE |
Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00058838 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
To assess the safety profile of sumanirole and the benefit of sumanirole in quality of life measures compared to placebo | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease | ||||
Official Title ICMJE | 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 ICMJE | Interventional | ||||
Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition ICMJE | Parkinson Disease | ||||
Intervention ICMJE | Drug: sumanirole | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 854 | ||||
Completion Date | September 2004 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | 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 ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States, Argentina, Australia, Austria, Belgium, Colombia, France, Germany, Greece, Italy, Mexico, Peru, Puerto Rico, Spain | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00058838 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | DA2APD-0075-031 | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Pfizer | ||||
Verification Date | June 2006 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |