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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 May 12, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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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Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease
Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Parkinson Disease
Drug: sumanirole
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
984
December 2004
Not Provided

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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Colombia,   Puerto Rico,   United States
 
 
NCT00036205
M27600011
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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