Category: Parkinson’s Disease: Clinical Trials
Objective: This study aimed to assess the efficacy of levodopa/benserazide dispersible tablet on delayed ON in Parkinson’s disease (PD) patients with motor fluctuation.
Background: Delayed ON is a phenomenon in which the levodopa effect does not appear within 40 minutes after taking levodopa, affecting patients’ daily lives, especially for those with motor fluctuations. One of the mechanisms is delayed absorption of levodopa as gastric emptying is often delayed in PD patients. To overcome delayed ON phenomenon, therapeutic interventions have been tried but there are only a few evidences established with variable regimens of levodopa.
Levodopa/benserazide dispersible tablet is an easily dissolvable formulation with a small amount of water, and can shorten the gastric passage time so that it reaches the small intestine quickly.
Method: This multicenter randomized open-label cross-over trial included a total of 40 patients with PD with delayed ON based on predefined criteria. Participants were randomized in a 1:1 ratio to receive either levodopa/benserazide 100 mg dispersible tablet followed by regular tablet, or regular tablet followed by dispersible tablet. They added the study medication on the first-morning dose and stabilized on each medication for 4 weeks with a washout period of 1 week. The primary outcome was the difference of the time to ON state after the first-morning dose based on special diary after 4 weeks of each therapy. We also evaluated the impact of dispersible and regular tablets on motor fluctuations and parkinsonian symptoms at each time point. Paired t-test and repeated measure analysis of variance were applied to estimate the difference of the time to ON between dispersible and regular tablets.
Results: A total of 40 participants were included in this study. The time to ON state after the first-morning dose was significantly reduced in the dispersible tablet compared with the regular tablet (-34.72 vs -23.81 minutes, p=0.014). There were no significant differences in PD symptoms as measured by the Unified Parkinson’s Disease Rating Scale and the Unified Dyskinesia Rating Scale between the two tablets.
Conclusion: Levodopa/benserazide dispersible tablets improved the delayed ON time in Parkinson’ disease patients with motor fluctuations and there was no exacerbation of levodopa-induced dyskinesia.
To cite this abstract in AMA style:HJ. Chang, J. Park, S. Oh, CW. Shin, JW. Cho, JY. Lee. Efficacy of levodopa/benserazide dispersible tablet on delayed ON in Parkinson’s disease patients with motor fluctuations: a multicenter randomized open-label cross-over trial [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/efficacy-of-levodopa-benserazide-dispersible-tablet-on-delayed-on-in-parkinsons-disease-patients-with-motor-fluctuations-a-multicenter-randomized-open-label-cross-over-trial/. Accessed March 5, 2024.
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MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-of-levodopa-benserazide-dispersible-tablet-on-delayed-on-in-parkinsons-disease-patients-with-motor-fluctuations-a-multicenter-randomized-open-label-cross-over-trial/