Phase 4
Completed N=82
Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily
Source: ClinicalTrials.gov NCT00986245 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcomePrimary: Patient Preference — 17; 31; 13 participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Preference |
17; 31; 13 | — |
| SECONDARY Unified Parkinson's Disease Rating Scale, Part 3 |
17.5; 17.1 | <0.05 sig |
| SECONDARY Hoehn and Yahr Stage |
2.1; 2.1 | <0.05 sig |
| SECONDARY Overall Quality of Sleep |
2.9; 3.2 | <0.05 sig |
| SECONDARY Nocturnal Off-symptoms |
2.9; 3.1 | <0.05 sig |
| SECONDARY Early Morning Off Symptoms |
2.5; 2.9 | <0.05 sig |
| SECONDARY Epworth Sleep Scale |
6.3; 6.4 | <0.05 sig |
| SECONDARY Compliance |
98.4; 97.6 | <0.05 sig |
| SECONDARY Adverse Events |
33; 28 | — |
| SECONDARY Patients Who Have Global Impression for Improvement |
32; 42 | — |
| SECONDARY Patients Who Have Global Impression for Improvement to Duration of Motor Fluctuation |
27; 38 | — |
| SECONDARY Patients Who Have Global Impression for Improvement to Severity of Motor Fluctuation |
28; 34 | — |
| SECONDARY Patients Who Have Global Impression for Improvement to Duration of Dyskinesia |
13; 16 | — |
| SECONDARY Patients Who Have Global Impression for Improvement to Severity of Dyskinesia |
16; 15 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00986245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.