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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ropinirole Prolonged release
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Ropinirole

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital
  • Boramae City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ropinirole PR QD first, then BID

Ropinirole PR BID first, and then QD

Arm Description

Give Roipinirole prolonged release (PR) once-daily (QD) dose first, then twice-daily (BID) dosing

Give Ropinirole prolonged release (PR) twice-daily (BID) dosing, and then once-daily (QD) dosing

Outcomes

Primary Outcome Measures

Patient Preference
Patient preference between once-daily and twice-daily regimen

Secondary Outcome Measures

Unified Parkinson's Disease Rating Scale, Part 3
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
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
Sleep questionnaire 1 for "Overall quality of sleep" Visual analogue scale: 0~10 Higher values represent worse overall sleep quality.
Nocturnal Off-symptoms
Sleep questionnaire 2 for "Nocturnal off-symptoms" Visual analogue scale: 0~10 Higher values represent worse nocturnal off-symptoms.
Early Morning Off Symptoms
Sleep questionnaire 3 for "early morning off symptoms" Visual analogue scale: 0~10 Higher values represent worse early morning off symptoms.
Epworth Sleep Scale
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
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
Patients who have adverse events
Patients Who Have Global Impression for Improvement
Patients who have global impression for improvement for each dosing.
Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation
Patients who have global impression for improvement to duration of motor fluctuation
Patients Who Have Global Impression for Improvement to Severity of Motor Fluctuation
Patients who have global impression for improvement to severity of motor fluctuation compared
Patients Who Have Global Impression for Improvement to Duration of Dyskinesia
Patients who have global impression for improvement to duration of dyskinesia compared
Patients Who Have Global Impression for Improvement to Severity of Dyskinesia
Patients who have Global Impression for Improvement to Severity of Dyskinesia compared

Full Information

First Posted
September 24, 2009
Last Updated
September 4, 2013
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00986245
Brief Title
Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, Ropinirole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropinirole PR QD first, then BID
Arm Type
Active Comparator
Arm Description
Give Roipinirole prolonged release (PR) once-daily (QD) dose first, then twice-daily (BID) dosing
Arm Title
Ropinirole PR BID first, and then QD
Arm Type
Active Comparator
Arm Description
Give Ropinirole prolonged release (PR) twice-daily (BID) dosing, and then once-daily (QD) dosing
Intervention Type
Drug
Intervention Name(s)
Ropinirole Prolonged release
Other Intervention Name(s)
Requip PD®
Intervention Description
Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily
Primary Outcome Measure Information:
Title
Patient Preference
Description
Patient preference between once-daily and twice-daily regimen
Time Frame
After 16 weeks or at last visit for early completion
Secondary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale, Part 3
Description
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.
Time Frame
8 weeks for each arm or at last visit
Title
Hoehn and Yahr Stage
Description
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
Time Frame
8 weeks for each arm or at last visit
Title
Overall Quality of Sleep
Description
Sleep questionnaire 1 for "Overall quality of sleep" Visual analogue scale: 0~10 Higher values represent worse overall sleep quality.
Time Frame
8 weeks for each arm or at last visit
Title
Nocturnal Off-symptoms
Description
Sleep questionnaire 2 for "Nocturnal off-symptoms" Visual analogue scale: 0~10 Higher values represent worse nocturnal off-symptoms.
Time Frame
8 weeks for each arm or at last visit
Title
Early Morning Off Symptoms
Description
Sleep questionnaire 3 for "early morning off symptoms" Visual analogue scale: 0~10 Higher values represent worse early morning off symptoms.
Time Frame
8 weeks for each arm or at last visit
Title
Epworth Sleep Scale
Description
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.
Time Frame
8 weeks in each arm or at last visit for early completion
Title
Compliance
Description
Compliances after 8 weeks in each arm or at last visit for early completion. Compliance was calcuated by the percentage of used medication.
Time Frame
8 weeks for each arm or at last visit
Title
Adverse Events
Description
Patients who have adverse events
Time Frame
After 8 weeks in each arm or at last visit for early completion
Title
Patients Who Have Global Impression for Improvement
Description
Patients who have global impression for improvement for each dosing.
Time Frame
After 8 weeks in each arm or at last visit for early completion
Title
Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation
Description
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
Title
Patients Who Have Global Impression for Improvement to Severity of Motor Fluctuation
Description
Patients who have global impression for improvement to severity of motor fluctuation compared
Time Frame
After 8 weeks in each arm or at last visit for early completion
Title
Patients Who Have Global Impression for Improvement to Duration of Dyskinesia
Description
Patients who have global impression for improvement to duration of dyskinesia compared
Time Frame
After 8 weeks in each arm or at last visit for early completion
Title
Patients Who Have Global Impression for Improvement to Severity of Dyskinesia
Description
Patients who have Global Impression for Improvement to Severity of Dyskinesia compared
Time Frame
After 8 weeks in each arm or at last visit for early completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beom S Jeon, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Boramae City Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19768728
Citation
Lyons KE, Pahwa R. An open-label conversion study of pramipexole to ropinirole prolonged release in Parkinson's disease. Mov Disord. 2009 Oct 30;24(14):2121-7. doi: 10.1002/mds.22750.
Results Reference
background
PubMed Identifier
18768106
Citation
Stocchi F, Hersh BP, Scott BL, Nausieda PA, Giorgi L; Ease-PD Monotherapy Study Investigators. Ropinirole 24-hour prolonged release and ropinirole immediate release in early Parkinson's disease: a randomized, double-blind, non-inferiority crossover study. Curr Med Res Opin. 2008 Oct;24(10):2883-95. doi: 10.1185/03007990802387130. Epub 2008 Sep 2.
Results Reference
background
PubMed Identifier
24004540
Citation
Yun JY, Kim HJ, Lee JY, Kim YE, Kim JS, Kim JM, Jeon BS. Comparison of once-daily versus twice-daily combination of ropinirole prolonged release in Parkinson's disease. BMC Neurol. 2013 Sep 2;13:113. doi: 10.1186/1471-2377-13-113.
Results Reference
derived

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

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