Pramipexole Conversion to Ropinirole Controlled Release (CR)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Rajesh Pahwa, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00275275
First received: January 9, 2006
Last updated: July 21, 2012
Last verified: July 2012

January 9, 2006
July 21, 2012
January 2006
May 2008   (final data collection date for primary outcome measure)
Adverse Effects Experienced [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
Number of adverse effect experienced by participants in the different conversion ratio groups.
Primary outcome variables to examine the efficacy of ropinirole will be the PDQ-39 and global rating scales
Complete list of historical versions of study NCT00275275 on ClinicalTrials.gov Archive Site
Number of Dose Adjustments [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced.
Parkinsonian rating scales and adverse events
Not Provided
Not Provided
 
Pramipexole Conversion to Ropinirole Controlled Release (CR)
An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease.

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson Disease
  • Drug: Requip PR
    Requip 24-Hour once a day for one month
    Other Name: Requip 24-hour prolonged release (PR).
  • Drug: Mirapex
    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.
    Other Name: Pramipexole
  • Experimental: 1
    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.
    Interventions:
    • Drug: Requip PR
    • Drug: Mirapex
  • Experimental: 2
    Conversion factor of Mirapex to Requip 24-Hour of 1:4
    Interventions:
    • Drug: Requip PR
    • Drug: Mirapex
  • Experimental: 3
    Conversion factor of Mirapex to Requip 24-Hour of 1:5
    Interventions:
    • Drug: Requip PR
    • Drug: Mirapex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
May 2008
May 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00275275
10161
No
Rajesh Pahwa, MD, University of Kansas Medical Center Research Institute
Rajesh Pahwa, MD
GlaxoSmithKline
Principal Investigator: Rajesh Pahwa, MD University of Kansas
University of Kansas
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP