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: This study is registered with ClinicalTrials.gov, number NCT00986245.
Bibliographical noteFunding Information:
This study was supported by a grant of the Korea Health technology R&D Project, Ministry of Health & Welfare, Republic of Korea. (A101273, BSJ). The study sponsor was not involved in study design, data analysis, interpretation of the data and in the decision to submit the paper for publication. This study was not sponsored by pharmaceutical companies.
BSJ has received funding for travel from Norvartis Korea and GlaxoSmithKline Korea and has received research support as PI from Norvartis, Boehringer Ingelheim, Ipsen, the Korea Health 21 R&D project, Ministry of Health & Welfare, Republic of Korea (A101273), the National Research Foundation of Korea(NRF), Ministry of Education, Science and Technology (2010–0021653), ABRC (Advanced Biometric Research Center), KOSEF (Korean Science and Engineering Foundation), Seoul National University Hospital, the Mr. Chung Suk-Gyoo and Sinyang Cultural Foundation, and the Song Foundation. Other authors have no financial disclosures.
- Dopamine agonist
- Motor control
- Movement disorders
- Parkinson's disease