Pramipexole Conversion to Ropinirole Controlled Release (CR)

Study Overview
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Brief Summary
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A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in patients with Parkinson's disease to determine the appropriate conversion ratio and side effects related to the drug.

Detailed Description
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Three different arms will be used in this study. Each of the three cohorts will be treated sequentially. Each participant will be taking Mirapex for PD and will be converted to Requip CR by 1 of 3 conversion factors (mg:mg): 1:3, 1:4 and 1:5 from Mirapex to once a day Requip CR. The first five subjects of each cohort will have their initial dose administered in the clinic and be monitored for orthostatic changes. Assessments of motor function before and after conversion will be done.

Official Title
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An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease.

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Requip PR
* Drug: Mirapex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Parkinson Disease Currently taking pramipexole Never have taken Requip CR Exclusion Criteria: Can not have significant adverse effects to standard Requip Can not have atypical PD due to drugs, metabolic disorders, encephalitis or degenerative diseases Can not have unstable medical conditions Can not be taking concurrent monoamine oxidase inhibitors except for selegiline (10mg per day or less) Female patients of childbearing potential must be using an effective method of contraception. Can not be pregnant or lactating. This may not be a complete list; there may be additional criteria which may apply.

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Conversion factor of Mirapex to Requip 24-Hour of 1:3. This was a switch study in which the conversion factor was being investigated to assist in the conversion from Mirapex to Requip PR. In this group, the dose of Requip PR was 3 times the dose of Mirapex. | Drug: Requip PR<br>* Requip 24-Hour once a day for one month<br>* Other names: Requip 24-hour prolonged release (PR).;Drug: Mirapex<br>* All subjects started the study on Mirapex. They were all then switched to Requip PR based on a conversion factor of 1:3, 1:4 or 1:5.<br>* Other names: Pramipexole;|
| Experimental: 2<br>Conversion factor of Mirapex to Requip 24-Hour of 1:4 | Drug: Requip PR<br>* Requip 24-Hour once a day for one month<br>* Other names: Requip 24-hour prolonged release (PR).;Drug: Mirapex<br>* All subjects started the study on Mirapex. They were all then switched to Requip PR based on a conversion factor of 1:3, 1:4 or 1:5.<br>* Other names: Pramipexole;|
| Experimental: 3<br>Conversion factor of Mirapex to Requip 24-Hour of 1:5 | Drug: Requip PR<br>* Requip 24-Hour once a day for one month<br>* Other names: Requip 24-hour prolonged release (PR).;Drug: Mirapex<br>* All subjects started the study on Mirapex. They were all then switched to Requip PR based on a conversion factor of 1:3, 1:4 or 1:5.<br>* Other names: Pramipexole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Effects Experienced | Number of adverse effect experienced by participants in the different conversion ratio groups. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Dose Adjustments | Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced. | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD, Parkinson's