Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT00036205|
Recruitment Status : Terminated
First Posted : May 9, 2002
Last Update Posted : January 18, 2007
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: sumanirole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||984 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.|
|Study Start Date :||August 2000|
|Study Completion Date :||December 2004|
- The primary objective is to assess the long term safety and tolerability of sumanirole by measuring Safety labs, ECG monitoring, vital signs and adverse events, over a period of up to 4 years.
- Pharmacoeconomics, quality of life, and the long term therapeutic response associated with sumanirole by using Parts II and III of the UPDRS (Unified Parkinson's Disease Rating Scale).
- Part II -- Activities of Daily Living, will be collected in order to record the patient's level of function between visits.
- Part III will be used to evaluate motor function.
- Three quality of life instruments will be employed: a general scale--the Functional Status Questionnaire, a disease specific scale--the Parkinson's Disease Questionnaire, and a utility scale--the EuroQol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036205
|Study Director:||Pfizer CT.gov Call Center||Pfizer|