Back to resultsPramipexole Conversion to Ropinirole Controlled Release (CR)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Requip PR
Mirapex
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring PD, Parkinson's
Eligibility Criteria
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.
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
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.
Conversion factor of Mirapex to Requip 24-Hour of 1:4
Conversion factor of Mirapex to Requip 24-Hour of 1:5
Outcomes
Primary Outcome Measures
Adverse Effects Experienced
Number of adverse effect experienced by participants in the different conversion ratio groups.
Secondary Outcome Measures
Number of Dose Adjustments
Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced.
Full Information
NCT ID
NCT00275275
First Posted
January 9, 2006
Last Updated
July 21, 2012
Sponsor
Rajesh Pahwa, MD
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00275275
Brief Title
Pramipexole Conversion to Ropinirole Controlled Release (CR)
Official Title
An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rajesh Pahwa, MD
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
PD, Parkinson's
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
Conversion factor of Mirapex to Requip 24-Hour of 1:4
Arm Title
3
Arm Type
Experimental
Arm Description
Conversion factor of Mirapex to Requip 24-Hour of 1:5
Intervention Type
Drug
Intervention Name(s)
Requip PR
Other Intervention Name(s)
Requip 24-hour prolonged release (PR).
Intervention Description
Requip 24-Hour once a day for one month
Intervention Type
Drug
Intervention Name(s)
Mirapex
Other Intervention Name(s)
Pramipexole
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Effects Experienced
Description
Number of adverse effect experienced by participants in the different conversion ratio groups.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Number of Dose Adjustments
Description
Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced.
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Pahwa, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pramipexole Conversion to Ropinirole Controlled Release (CR)
We'll reach out to this number within 24 hrs