Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease
|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)|
|Estimated 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|
|Estimated 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036205
Show 110 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|