Clinical trial NCT00986245: Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily
Official title: An Open-label, Multi-center, Crossover Study to Compare the Effect of Once-daily Ropinirole PR and Twice-daily Ropinirole PR in Patients With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Keywords: Parkinson disease
Ropinirole
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-09-29
Enrollment: 82
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 dopamine agonists into Ropinirole prolonged release

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Preference
timeFrame: After 16 weeks or at last visit for early completion
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale, Part 3
timeFrame: 8 weeks for each arm or at last visit
measure: Hoehn and Yahr Stage
timeFrame: 8 weeks for each arm or at last visit
measure: Overall Quality of Sleep
timeFrame: 8 weeks for each arm or at last visit
measure: Nocturnal Off-symptoms
timeFrame: 8 weeks for each arm or at last visit
measure: Early Morning Off Symptoms
timeFrame: 8 weeks for each arm or at last visit
measure: Epworth Sleep Scale
timeFrame: 8 weeks in each arm or at last visit for early completion
measure: Compliance
timeFrame: 8 weeks for each arm or at last visit
measure: Adverse Events
timeFrame: After 8 weeks in each arm or at last visit for early completion
measure: Patients Who Have Global Impression for Improvement
timeFrame: After 8 weeks in each arm or at last visit for early completion
measure: Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation
timeFrame: After 8 weeks in each arm or at last visit for early completion
measure: Patients Who Have Global Impression for Improvement to Severity of Motor Fluctuation
timeFrame: After 8 weeks in each arm or at last visit for early completion
measure: Patients Who Have Global Impression for Improvement to Duration of Dyskinesia
timeFrame: After 8 weeks in each arm or at last visit for early completion
measure: Patients Who Have Global Impression for Improvement to Severity of Dyskinesia
timeFrame: After 8 weeks in each arm or at last visit for early completion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Boramae City Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Beom S Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyons KE, Pahwa R. An open-label conversion study of pramipexole to ropinirole prolonged release in Parkinson's disease. Mov Disord. 2009 Oct 30;24(14):2121-7. doi: 10.1002/mds.22750.
citation: Stocchi F, Hersh BP, Scott BL, Nausieda PA, Giorgi L; Ease-PD Monotherapy Study Investigators. Ropinirole 24-hour prolonged release and ropinirole immediate release in early Parkinson's disease: a randomized, double-blind, non-inferiority crossover study. Curr Med Res Opin. 2008 Oct;24(10):2883-95. doi: 10.1185/03007990802387130. Epub 2008 Sep 2.
citation: Yun JY, Kim HJ, Lee JY, Kim YE, Kim JS, Kim JM, Jeon BS. Comparison of once-daily versus twice-daily combination of ropinirole prolonged release in Parkinson's disease. BMC Neurol. 2013 Sep 2;13:113. doi: 10.1186/1471-2377-13-113.