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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-12-31

Brief Summary

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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 dopamine agonists into Ropinirole prolonged release

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Detailed Description

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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 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
3. Dose adjustment may be done in the first 4 weeks.
4. Compare the benefit,side effects, and patient preference between the once daily vs twice daily dosing.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ropinirole PR QD first, then BID

Give Roipinirole prolonged release (PR) once-daily (QD) dose first, then twice-daily (BID) dosing

Group Type ACTIVE_COMPARATOR

Ropinirole Prolonged release

Intervention Type DRUG

Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily

Ropinirole PR BID first, and then QD

Give Ropinirole prolonged release (PR) twice-daily (BID) dosing, and then once-daily (QD) dosing

Group Type ACTIVE_COMPARATOR

Ropinirole Prolonged release

Intervention Type DRUG

Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily

Interventions

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Ropinirole Prolonged release

Change Ropinirole immediate release or Pramipexole immediate release to Ropinirole prolonged release (PR) once-daily or twice-daily

Intervention Type DRUG

Other Intervention Names

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Requip PD®

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Who are on less than 2 mg of Ropinirole IR or 0.375 mg of Pramipexole IR
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. Whoa re pregnant or lactating
7. Who are considered not eligible by the investigator

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No