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Clinical Trial
. 2013 Sep 2:13:113.
doi: 10.1186/1471-2377-13-113.

Comparison of once-daily versus twice-daily combination of ropinirole prolonged release in Parkinson's disease

Ji Young Yun  1 , Han-Joon Kim, Jee-Young Lee, Young Eun Kim, Ji Seon Kim, Jong-Min Kim, Beom S Jeon
Affiliations
Clinical Trial

Comparison of once-daily versus twice-daily combination of ropinirole prolonged release in Parkinson's disease

Ji Young Yun et al. BMC Neurol. .

Abstract

Background: Ropinirole prolonged release (RPR) is a once-daily formulation. However, there may be individual pharmacokinetic differences so that multiple dosing may be preferred in some individuals. This study compares once-daily and twice-daily RPR in patients with Parkinson's disease.

Methods: This study was an open-label crossover study. We enrolled Parkinson's disease patients on dopamine agonist therapy with unsatisfactory control such as motor fluctuation, dyskinesia and sleep-related problems. Agonists were switched into equivalent dose of RPR. Subjects were consecutively enrolled into either once-daily first or twice-daily first groups, and received the same amount of RPR in a single and two divided dosing for 8 weeks respectively in a crossover manner without a washout period.The primary outcome was a questionnaire of the preference completed by patients in the last visit. The secondary outcome measures included the Unified Parkinson's Disease Rating Scale part 3 (mUPDRS), Hoehn and Yahr stage (H&Y); sleep questionnaire including overall quality of sleep, nocturnal off symptoms and early morning symptoms; Epworth Sleep Scale (ESS); compliances and patient global impression (PGI).

Results: A total of 82 patients were enrolled and 61 completed the study. 31 patients preferred twice-daily regimen, 17 preferred the once-daily regimen, and 13 had no preference. Their mean mUPDRS, H&Y, ESS, sleep quality, compliance and adverse events were not statistically different in both regimens. PGI-improvement on wearing off defined was better in twice-daily dosing regimen.

Conclusions: RPR is a once-daily formulation, but multiple dosing was preferred in many patients. Multiple dosing of RPR might be a therapeutic option if once-daily dosing is unsatisfactory.

Trial registration: ClinicalTrials.gov NCT00986245.

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Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Subject flow chart.
Figure 3
Figure 3
Patient’s preferences and reasons.
See this image and copyright information in PMC

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