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Pramipexole Conversion to Ropinirole Controlled Release (CR)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Rajesh Pahwa, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00275275
First received: January 9, 2006
Last updated: July 21, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
 Drug: Requip PR
Drug: Mirapex
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Adverse Effects Experienced [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    Number of adverse effect experienced by participants in the different conversion ratio groups.


Secondary Outcome Measures:
  • Number of Dose Adjustments [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced.


Enrollment: 61
Study Start Date: January 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Drug: Requip PR
Requip 24-Hour once a day for one month
Other Name: Requip 24-hour prolonged release (PR).
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.
Other Name: Pramipexole
Experimental: 2
Conversion factor of Mirapex to Requip 24-Hour of 1:4
 Drug: Requip PR
Requip 24-Hour once a day for one month
Other Name: Requip 24-hour prolonged release (PR).
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.
Other Name: Pramipexole
Experimental: 3
Conversion factor of Mirapex to Requip 24-Hour of 1:5
 Drug: Requip PR
Requip 24-Hour once a day for one month
Other Name: Requip 24-hour prolonged release (PR).
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.
Other Name: Pramipexole

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00275275

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Rajesh Pahwa, MD
GlaxoSmithKline
Investigators
Principal Investigator: Rajesh Pahwa, MD University of Kansas
  More Information

No publications provided

Responsible Party: Rajesh Pahwa, MD, Professor and Director, Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00275275     History of Changes
Other Study ID Numbers: 10161
Study First Received: January 9, 2006
Results First Received: May 2, 2012
Last Updated: July 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Kansas:
PD
Parkinson's

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexol
Ropinirole
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 19, 2013