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Pramipexole Conversion to Ropinirole Controlled Release (CR)

Information source: University of Kansas
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson Disease

Intervention: Requip PR (Drug); Mirapex (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Rajesh Pahwa, MD

Official(s) and/or principal investigator(s):
Rajesh Pahwa, MD, Principal Investigator, Affiliation: University of Kansas

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Adverse Effects Experienced

Secondary outcome: Number of Dose Adjustments

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University of Kansas Medical Center, Kansas City, Kansas 66160, United States
Additional Information

Starting date: January 2006
Last updated: July 21, 2012

Page last updated: August 23, 2015

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