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Trial record 1 of 1 for:    NCT00036205
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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
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 8, 2002
First Posted Date  ICMJE May 9, 2002
Last Update Posted Date January 18, 2007
Study Start Date  ICMJE August 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2007)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2007)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease
Official Title  ICMJE Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.
Brief Summary The primary objective is to assess the long term safety and tolerability of sumanirole as measured by safety labs, ECG monitoring, vital signs, and adverse event reports in subjects with Parkinson's Disease who participated in previous sumanirole studies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Drug: sumanirole
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: January 17, 2007)
984
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE December 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Idiopathic Parkinson's disease
  • Modified Hoehn and Yahr Scale Stages 1-4
  • Age over 30 years
  • Previous participation in prior sumanirole studies

Exclusion Criteria:

  • Use of dopamine agonist medications and other medications in defined timeframe
  • Unstable dose of CNS active therapies (eg, hypnotics, antidepressants, anxiolytics) within the last 30 days
  • Atypical Parkinson's syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases
  • Dementia
  • History of active epilepsy within the past year
  • Significant liver disease with defined laboratory criteria
  • Significant renal disease with defined laboratory criteria
  • Certain cardiac conditions
  • Electroconvulsive therapy in the previous 90 days
  • Subjects participating in other drug studies or receiving other investigational drugs within previous 30 days
  • Positive pregnancy test at Screen
  • Unwillingness to use adequate contraceptive methods
  • Lactating women
  • History of stereotaxic brain surgery
  • Malignant melanoma or history of treated melanoma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Colombia,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00036205
Other Study ID Numbers  ICMJE M27600011
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP