Pramipexole Conversion to Ropinirole Controlled Release (CR)

NCT00275275 | Completed Phase 3 Results

• 1 other identifier: 10161
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

PD; Parkinson's

Outcome Measures

Primary Outcomes (1)

• Adverse Effects Experienced

  Number of adverse effect experienced by participants in the different conversion ratio groups.

  Week 4

Secondary Outcomes (1)

• Number of Dose Adjustments

  Week 4

Study Arms (3)

1

EXPERIMENTAL

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.

Drug: Requip PR; Drug: Mirapex

2

EXPERIMENTAL

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

Drug: Requip PR; Drug: Mirapex

3

EXPERIMENTAL

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

Drug: Requip PR; Drug: Mirapex

Interventions

Requip PR DRUG

Requip 24-Hour once a day for one month

Also known as: Requip 24-hour prolonged release (PR).

1; 2; 3

Mirapex 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.

Also known as: Pramipexole

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson Disease
• Currently taking pramipexole
• Never have taken Requip CR

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rajesh Pahwa, MD: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

ropinirole; Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Kelly E. Lyons, PhD
• Organization: University of Kansas Medical Center

klyons@kumc.edu

913-588-7159

Study Officials

• Rajesh Pahwa, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Director, Parkinson's Disease and Movement Disorder Center

Study Record Dates

• First Submitted: January 9, 2006
• First Posted: January 11, 2006
• Study Start: January 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 24, 2012
• Results First Posted: August 24, 2012

Record last verified: 2012-07

Locations

US (1)