Pramipexole Conversion to Ropinirole Controlled Release (CR)

Rajesh Pahwa, MD

Status and phase: Completed; Phase 3

Conditions: Parkinson Disease

Treatments: Drug: Requip PR; Drug: Mirapex

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00275275

10161

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 3 patient groups

1

Experimental group

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.

Treatment:

Drug: Mirapex

Drug: Requip PR

2

Experimental group

Description:

Conversion factor of Mirapex to Requip 24-Hour of 1:4

Treatment:

Drug: Mirapex

Drug: Requip PR

3

Experimental group

Description:

Conversion factor of Mirapex to Requip 24-Hour of 1:5

Treatment:

Drug: Mirapex

Drug: Requip PR