Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's Disease
NCT00036205
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Idiopathic Parkinson's disease
- Modified Hoehn and Yahr Scale Stages 1-4
- Age over 30 years
- Previous participation in prior sumanirole studies
- 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
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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 | 984 | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | December 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |