Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily

September 4, 2013 updated by: BS Jeon, Seoul National University Hospital

An Open-label, Multi-center, Crossover Study to Compare the Effect of Once-daily Ropinirole PR and Twice-daily Ropinirole PR in Patients With Parkinson Disease

  1. In order to compare the benefit, side effects, and patient preference of Ropinirole prolonged release when used in once-daily or twice-daily dosing
  2. In order to estimate the conversion rate of dopamine agonists into Ropinirole prolonged release

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Study subjects : Parkinson disease who are on Ropinirole immediate release or Pramipexole immediate release and are considering to change into Ropinirole prolonged release

  2. Cross over study design:

    • Group 1: once daily dose for 2 month then into twice daily in divided dose for 2 months
    • Group 2: twice daily in divided dose for 2 months then into once daily dose for 2 months
  3. Dose adjustment may be done in the first 4 weeks.
  4. Compare the benefit,side effects, and patient preference between the once daily vs twice daily dosing.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Boramae City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 30-80
  2. Parkinson disease
  3. On dopamine agonists (Ropinirole IR or Pramipexole IR) and are considering to change into Ropinirole PR
  4. On stable antiparkinsonian medication for at least 4 weeks
  5. Who signed consent to the study

Exclusion Criteria:

  1. Who are on less than 2 mg of Ropinirole IR or 0.375 mg of Pramipexole IR
  2. Who have dementia, psychosis, major depression and other serious neurological or medical problems
  3. Who are allergic to the similar medications
  4. Who has history of heavy metal poisoning
  5. Who were on othe clinical trials of other medications within the last 4 weeks
  6. Whoa re pregnant or lactating
  7. Who are considered not eligible by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ropinirole PR QD first, then BID
Give Roipinirole prolonged release (PR) once-daily (QD) dose first, then twice-daily (BID) dosing
Drug: Ropinirole Prolonged release
Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily
Other Names:
  • Requip PD®
Active Comparator: Ropinirole PR BID first, and then QD
Give Ropinirole prolonged release (PR) twice-daily (BID) dosing, and then once-daily (QD) dosing
Drug: Ropinirole Prolonged release
Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily
Other Names:
  • Requip PD®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Preference
Time Frame: After 16 weeks or at last visit for early completion
Patient preference between once-daily and twice-daily regimen
After 16 weeks or at last visit for early completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale, Part 3
Time Frame: 8 weeks for each arm or at last visit

Unified Parkinson's disease rating scale (UPDRS) motor scale after 8 weeks in each arm or at last visit for early completion.

UPDRS part 3 is motor scale for parkinson's disease. Range: 0~108 Higher values represent more severe motor symptoms of parkinsonism.
8 weeks for each arm or at last visit
Hoehn and Yahr Stage
Time Frame: 8 weeks for each arm or at last visit
Hoehn and Yahr(HY) stage for parkinsonism after 8 weeks in each arm or at last visit for early completion Range: 0~5 Higher values represent more severe parkinsonism
8 weeks for each arm or at last visit
Overall Quality of Sleep
Time Frame: 8 weeks for each arm or at last visit
Sleep questionnaire 1 for "Overall quality of sleep" Visual analogue scale: 0~10 Higher values represent worse overall sleep quality.
8 weeks for each arm or at last visit
Nocturnal Off-symptoms
Time Frame: 8 weeks for each arm or at last visit
Sleep questionnaire 2 for "Nocturnal off-symptoms" Visual analogue scale: 0~10 Higher values represent worse nocturnal off-symptoms.
8 weeks for each arm or at last visit
Early Morning Off Symptoms
Time Frame: 8 weeks for each arm or at last visit
Sleep questionnaire 3 for "early morning off symptoms" Visual analogue scale: 0~10 Higher values represent worse early morning off symptoms.
8 weeks for each arm or at last visit
Epworth Sleep Scale
Time Frame: 8 weeks in each arm or at last visit for early completion

Epworth sleep scale after 8 weeks in each arm or at last visit for early completion.

Range: 0~24 Higher values represent worse daytime-sleepiness.
8 weeks in each arm or at last visit for early completion
Compliance
Time Frame: 8 weeks for each arm or at last visit
Compliances after 8 weeks in each arm or at last visit for early completion. Compliance was calcuated by the percentage of used medication.
8 weeks for each arm or at last visit
Adverse Events
Time Frame: After 8 weeks in each arm or at last visit for early completion
Patients who have adverse events
After 8 weeks in each arm or at last visit for early completion
Patients Who Have Global Impression for Improvement
Time Frame: After 8 weeks in each arm or at last visit for early completion
Patients who have global impression for improvement for each dosing.
After 8 weeks in each arm or at last visit for early completion
Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation
Time Frame: After 8 weeks in each arm or at last visit for early completion
Patients who have global impression for improvement to duration of motor fluctuation
After 8 weeks in each arm or at last visit for early completion
Patients Who Have Global Impression for Improvement to Severity of Motor Fluctuation
Time Frame: After 8 weeks in each arm or at last visit for early completion
Patients who have global impression for improvement to severity of motor fluctuation compared
After 8 weeks in each arm or at last visit for early completion
Patients Who Have Global Impression for Improvement to Duration of Dyskinesia
Time Frame: After 8 weeks in each arm or at last visit for early completion
Patients who have global impression for improvement to duration of dyskinesia compared
After 8 weeks in each arm or at last visit for early completion
Patients Who Have Global Impression for Improvement to Severity of Dyskinesia
Time Frame: After 8 weeks in each arm or at last visit for early completion
Patients who have Global Impression for Improvement to Severity of Dyskinesia compared
After 8 weeks in each arm or at last visit for early completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria

September 27, 2009

First Posted (Estimate)

September 29, 2009

Study Record Updates

Last Update Posted (Estimate)

September 9, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0908-037-290

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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