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Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease

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NCT00036205

Last updated on April 2, 2020
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Study Location
Pfizer Investigational Site
Birmingham, Alabama, United States
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Parkinson Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Idiopathic Parkinson's disease

- Modified Hoehn and Yahr Scale Stages 1-4

- Age over 30 years

- Previous participation in prior sumanirole studies

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00036205
Pfizer
Terminated
Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease

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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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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