Pramipexole Conversion to Ropinirole CR - Tabular View

Tracking Information

First Received Date ^ICMJE

January 9, 2006

Last Updated Date

June 24, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Primary outcome variables to examine the efficacy of ropinirole will be the PDQ-39 and global rating scales [ Time Frame: One month after drug conversion ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Primary outcome variables to examine the efficacy of ropinirole will be the PDQ-39 and global rating scales

Change History

Complete list of historical versions of study NCT00275275 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Parkinsonian rating scales and adverse events [ Time Frame: One month after drug conversion, Two months after drug conversion ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Parkinsonian rating scales and adverse events

Descriptive Information

Brief Title ^ICMJE

Pramipexole Conversion to Ropinirole CR

Official Title ^ICMJE

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

Brief Summary

A conversion study of pramipexole to 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 pramipexole for PD and will be converted to ropinirole CR by 1 of 3 conversion factors (mg:mg): 1:3, 1:4 and 1:5 from pramipexole to once a day ropinirole 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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Parkinson Disease

Intervention ^ICMJE

Drug: Ropinirole controlled release (CR)

Study Arms / Comparison Groups

Experimental: Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
Experimental: Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
Experimental: Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of Parkinson Disease
Currently taking pramipexole
Never have taken ropinirole CR

Exclusion Criteria:

Can not have significant adverse effects to standard ropinirole
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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00275275

Responsible Party

Rajesh Pahwa, MD, University of Kansas Medical Center

Study ID Numbers ^ICMJE

10161

Study Sponsor ^ICMJE

University of Kansas

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Rajesh Pahwa, MD

University of Kansas

Information Provided By

University of Kansas

Verification Date

June 2008

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