Pramipexole Conversion to Ropinirole CR - Full Text View

Sponsor:	University of Kansas
Collaborator:	GlaxoSmithKline
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00275275

Purpose

A conversion study of pramipexole to 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: Ropinirole controlled release (CR)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study
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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Ropinirole hydrochloride Ropinirole Pramipexol Pramipexole dihydrochloride

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:

Primary outcome variables to examine the efficacy of ropinirole will be the PDQ-39 and global rating scales [ Time Frame: One month after drug conversion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Parkinsonian rating scales and adverse events [ Time Frame: One month after drug conversion, Two months after drug conversion ] [ Designated as safety issue: Yes ]

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
1: Experimental Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3	Drug: Ropinirole controlled release (CR) Ropinirole 24-Hour once a day for one month
2: Experimental Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4	Drug: Ropinirole controlled release (CR) Ropinirole 24-Hour once a day for one month
3: Experimental Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5	Drug: Ropinirole controlled release (CR) Ropinirole 24-Hour once a day for one month

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 pramipexole for PD and will be converted to ropinirole CR by 1 of 3 conversion factors (mg:mg): 1:3, 1:4 and 1:5 from pramipexole to once a day ropinirole 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 ropinirole CR

Exclusion Criteria:

Can not have significant adverse effects to standard ropinirole
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

University of Kansas

GlaxoSmithKline

Investigators

Principal Investigator:

Rajesh Pahwa, MD

University of Kansas

More Information

No publications provided

Responsible Party:	University of Kansas Medical Center ( Rajesh Pahwa, MD )
Study ID Numbers:	10161
Study First Received:	January 9, 2006
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00275275 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Kansas:

PD
Parkinson's

Additional relevant MeSH terms:

Neurotransmitter Agents
Ropinirole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Antiparkinson Agents
Central Nervous System Diseases
Dopamine Agonists

Brain Diseases
Neurodegenerative Diseases
Protective Agents
Pramipexol
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009