Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)

Study Overview
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Brief Summary
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In order to observe the benefit, side effects, and patient preference of Mirapex ER when used in once-daily (QD) or twice-daily (BID) dosing In order to estimate the conversion rate of dopamine agonists into Mirapex ER

Detailed Description
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Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Mirapex ER Cross over study design: Group 1: Once daily dose for 2 month then into BID in divided dose for 2 months Group 2: BID in divided dose for 2 months then into QD dose for 2 months Dose adjustment may be done in the first 4 weeks. Compare the benefit, side effects, and patient preference between the QD vs BID dosing

Official Title
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An Open-label, Randomized, Multi-center, Crossover Study to Observe the Effect of Once-daily Mirapex ER® and Twice-daily Mirapex ER® in Patients With Parkinson Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Mirapex ER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 30-80 Parkinson disease On dopamine agonists (Requip or Mirapex) and are considering to change into Mirapex ER 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 Requip or 0.375 mg of Mirapex 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 Who are pregnant or lactating Who are considered not eligible by the investigator

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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: Group 1<br>Give QD dose first then BID dosing | Drug: Mirapex ER<br>* Change Requip or Mirapex to Mirapex ER<br>|
| Active Comparator: Group 2<br>Give BID dosing and then QD dosing | Drug: Mirapex ER<br>* Change Requip or Mirapex to Mirapex ER<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference | Overall preference in QD versus BID | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor complications | Visual rating scale for off severity, dyskinesia severity Duration - off duration, dyskinesia duration | 2 months at each arm | 
| Sleep problems | Parkinson's disease sleep scale (PDSS) Excessive daytime sleepiness scale(ESS) | 2 months at each arm | 
| Motor UPDRS and HY stage |  | 2months at each arm | 
| Side effects | Rating scale (0 10): Nausea, Dizziness, Somnolence, Headache, Constipation, Dyspepsia, Fatigue, Hallucination, Edema, Dry mouth,Others | 2 months at each arm | 
| Patient global impression for improvement |  | 2 months at each arm | 
| Preference in each factor | Preference of QD versus BID in each factor: off duration, off severity, dyskinesia duration, dyskinesia severity, on quality, adverse events, sleep quality, convenience | 4 months | 
| Patient choice | Patient choice in QD or BID Reason for the choice | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Pramipexole