Status:
COMPLETED
Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily
Lead Sponsor:
Seoul National University Hospital
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
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 do...
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 desig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00986245
Start Date
September 1 2009
End Date
December 1 2010
Last Update
September 9 2013
Active Locations (2)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744
2
Boramae City Hospital
Seoul, South Korea