Pramipexole Conversion to Ropinirole Controlled Release (CR)

Phase 3

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Requip PR; Drug: Mirapex

• Registration Number: NCT00275275
• Lead Sponsor: Rajesh Pahwa, MD

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-11
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2012-05-02
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-21
• Last Update Submitted: 2012-07-21
• Results First Posted: 2012-08-24
• Last Update Posted: 2012-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Requip PR	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.
2	Requip PR	Conversion factor of Mirapex to Requip 24-Hour of 1:4
3	Requip PR	Conversion factor of Mirapex to Requip 24-Hour of 1:5
3	Mirapex	Conversion factor of Mirapex to Requip 24-Hour of 1:5
1	Mirapex	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.
2	Mirapex	Conversion factor of Mirapex to Requip 24-Hour of 1:4

Primary Outcome Measures

Name	Time	Method
Adverse Effects Experienced	Week 4	Number of adverse effect experienced by participants in the different conversion ratio groups.

Secondary Outcome Measures

Name	Time	Method
Number of Dose Adjustments	Week 4	Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States