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

Study Overview
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Brief Summary
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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.

Official Title
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Open-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: sumanirole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sumanirole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  |