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Pramipexole Conversion to Ropinirole Controlled Release (CR)

NCT ID: NCT00275275

Last Updated: 2012-08-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Keywords

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PD Parkinson's

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Requip PR

Intervention Type DRUG

Requip 24-Hour once a day for one month

Mirapex

Intervention Type DRUG

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.

2

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

Group Type EXPERIMENTAL

Requip PR

Intervention Type DRUG

Requip 24-Hour once a day for one month

Mirapex

Intervention Type DRUG

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.

3

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

Group Type EXPERIMENTAL

Requip PR

Intervention Type DRUG

Requip 24-Hour once a day for one month

Mirapex

Intervention Type DRUG

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.

Interventions

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Requip PR

Requip 24-Hour once a day for one month

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Requip 24-hour prolonged release (PR). Pramipexole

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Rajesh Pahwa, MD

OTHER

Sponsor Role lead

Responsible Party

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Rajesh Pahwa, MD

Professor and Director, Parkinson's Disease and Movement Disorder Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rajesh Pahwa, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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10161

Identifier Type: -

Identifier Source: org_study_id