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Completed

NCT Number: NCT00986245

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

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

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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

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Boramae City Hospital, Seoul, South Korea

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About this study

  • Study subjects : Parkinson disease who are on Ropinirole immediate release or Pramipexole immediate release and are considering to change into Ropinirole prolonged release
  • 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
  • Dose adjustment may be done in the first 4 weeks.
  • Compare the benefit,side effects, and patient preference between the once daily vs twice daily dosing.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ropinirole prolonged release

Drug

Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily

Other names: Requip PD®

Primary outcomes

  1. Patient Preference

    Time frame: After 16 weeks or at last visit for early completion

    Patient preference between once-daily and twice-daily regimen

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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. Adverse Events

    Time frame: After 8 weeks in each arm or at last visit for early completion

    Patients who have adverse events

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 29, 2009
Registry last updated
Sep 9, 2013

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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