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

Phase 4

• Conditions: Parkinson's Disease
• Interventions: Drug: Mirapex ER

• Registration Number: NCT01515774
• Lead Sponsor: Seoul National University Hospital

Brief Summary

1. 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

2. In order to estimate the conversion rate of dopamine agonists into Mirapex ER

Detailed Description

1. Study subjects : Parkinson disease who are on Requip or Mirapex and are considering to change into Mirapex ER

2. 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

3. Dose adjustment may be done in the first 4 weeks.

4. Compare the benefit, side effects, and patient preference between the QD vs BID dosing

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Status Verified: 2012-01
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-18
• Last Update Submitted: 2012-01-18
• Study First Posted: 2012-01-24
• Last Update Posted: 2012-01-24
• Primary Completion: 2012-08
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age: 30-80
2. Parkinson disease
3. On dopamine agonists (Requip or Mirapex) and are considering to change into Mirapex ER
4. On stable antiparkinsonian medication for at least 4 weeks
5. Who signed consent to the study

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Exclusion Criteria

1. Who are on less than 2 mg of Requip or 0.375 mg of Mirapex
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. Who are pregnant or lactating
7. Who are considered not eligible by the investigator

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Mirapex ER	Give QD dose first then BID dosing
Group 2	Mirapex ER	Give BID dosing and then QD dosing

Primary Outcome Measures

Name	Time	Method
Patient preference	4 months	Overall preference in QD versus BID

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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