Status:
UNKNOWN
Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)
Lead Sponsor:
Seoul National University Hospital
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01515774
Start Date
September 1 2011
End Date
October 1 2012
Last Update
January 24 2012
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744