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

Study Overview
=================
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.

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

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Ropinirole Prolonged release


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Preference | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson disease, Ropinirole