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

Phase 4

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Ropinirole Prolonged release

• Registration Number: NCT00986245
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-27
• Study First Posted: 2009-09-29
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2012-07-07
• Status Verified: 2013-09
• Results First Submitted QC: 2013-09-04
• Last Update Submitted: 2013-09-04
• Results First Posted: 2013-09-09
• Last Update Posted: 2013-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ropinirole PR QD first, then BID	Ropinirole Prolonged release	Give Roipinirole prolonged release (PR) once-daily (QD) dose first, then twice-daily (BID) dosing
Ropinirole PR BID first, and then QD	Ropinirole Prolonged release	Give Ropinirole prolonged release (PR) twice-daily (BID) dosing, and then once-daily (QD) dosing

Primary Outcome Measures

Name	Time	Method
Patient Preference	After 16 weeks or at last visit for early completion	Patient preference between once-daily and twice-daily regimen

Secondary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale, Part 3	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.
Nocturnal Off-symptoms	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.
Hoehn and Yahr Stage	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
Overall Quality of Sleep	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.
Early Morning Off Symptoms	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.
Epworth Sleep Scale	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.
Compliance	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.
Adverse Events	After 8 weeks in each arm or at last visit for early completion	Patients who have adverse events
Patients Who Have Global Impression for Improvement	After 8 weeks in each arm or at last visit for early completion	Patients who have global impression for improvement for each dosing.
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 duration of motor fluctuation
Patients Who Have Global Impression for Improvement to Severity 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 compared
Patients Who Have Global Impression for Improvement to Duration of Dyskinesia	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
Patients Who Have Global Impression for Improvement to Severity of Dyskinesia	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

Trial Locations

Locations (2)

Boramae City Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of