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Completed

NCT Number: NCT00275275

Pramipexole Conversion to Ropinirole Controlled Release (CR)

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ReQuip PR

Drug

Requip 24-Hour once a day for one month

Other names: Requip 24-hour prolonged release (PR).

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.

Other names: Pramipexole

Primary outcomes

  1. Adverse Effects Experienced

    Time frame: Week 4

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

Secondary outcomes

  1. Number of Dose Adjustments

    Time frame: Week 4

    Outcome measures the number of times a dose needed to be adjusted to compensate for adverse effects experienced.

Sponsors and collaborators

Lead sponsor

Rajesh Pahwa, MD

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease.

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 11, 2006
Registry last updated
Aug 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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