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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BS Jeon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00986245
First received: September 24, 2009
Last updated: September 4, 2013
Last verified: September 2013
  Purpose
  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

Condition Intervention Phase
Parkinson Disease
Drug: Ropinirole Prolonged release
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Patient Preference [ Time Frame: After 16 weeks or at last visit for early completion ] [ Designated as safety issue: No ]
    Patient preference between once-daily and twice-daily regimen


Secondary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale, Part 3 [ Time Frame: 8 weeks for each arm or at last visit ] [ Designated as safety issue: No ]

    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.


  • Hoehn and Yahr Stage [ Time Frame: 8 weeks for each arm or at last visit ] [ Designated as safety issue: No ]
    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

  • Overall Quality of Sleep [ Time Frame: 8 weeks for each arm or at last visit ] [ Designated as safety issue: No ]
    Sleep questionnaire 1 for "Overall quality of sleep" Visual analogue scale: 0~10 Higher values represent worse overall sleep quality.

  • Nocturnal Off-symptoms [ Time Frame: 8 weeks for each arm or at last visit ] [ Designated as safety issue: No ]
    Sleep questionnaire 2 for "Nocturnal off-symptoms" Visual analogue scale: 0~10 Higher values represent worse nocturnal off-symptoms.

  • Early Morning Off Symptoms [ Time Frame: 8 weeks for each arm or at last visit ] [ Designated as safety issue: No ]
    Sleep questionnaire 3 for "early morning off symptoms" Visual analogue scale: 0~10 Higher values represent worse early morning off symptoms.

  • Epworth Sleep Scale [ Time Frame: 8 weeks in each arm or at last visit for early completion ] [ Designated as safety issue: No ]

    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.


  • Compliance [ Time Frame: 8 weeks for each arm or at last visit ] [ Designated as safety issue: No ]
    Compliances after 8 weeks in each arm or at last visit for early completion. Compliance was calcuated by the percentage of used medication.

  • Adverse Events [ Time Frame: After 8 weeks in each arm or at last visit for early completion ] [ Designated as safety issue: Yes ]
    Patients who have adverse events

  • Patients Who Have Global Impression for Improvement [ Time Frame: After 8 weeks in each arm or at last visit for early completion ] [ Designated as safety issue: No ]
    Patients who have global impression for improvement for each dosing.

  • 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 ] [ Designated as safety issue: No ]
    Patients who have global impression for improvement to duration of motor fluctuation

  • 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 ] [ Designated as safety issue: No ]
    Patients who have global impression for improvement to severity of motor fluctuation compared

  • 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 ] [ Designated as safety issue: No ]
    Patients who have global impression for improvement to duration of dyskinesia compared

  • 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 ] [ Designated as safety issue: No ]
    Patients who have Global Impression for Improvement to Severity of Dyskinesia compared


Enrollment: 82
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Requip PD®

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.
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986245

Locations
Korea, Republic of
Boramae City Hospital
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Beom S Jeon, MD, PhD Seoul National University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BS Jeon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00986245     History of Changes
Other Study ID Numbers: 0908-037-290
Study First Received: September 24, 2009
Results First Received: July 7, 2012
Last Updated: September 4, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Parkinson disease
Ropinirole

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

ClinicalTrials.gov processed this record on October 23, 2014