Objective: To investigate split tablet dosing of Levodopa/Carbidopa/Entacapone (LCE) 100mg/25mg/200mg in treating Chinese patients with early Parkinson’s disease (PD).

Background: LCE is a treatment option for early PD [1-3]. LCE 100mg/25mg/200mg tablet is the only dosage form available in China, making split tablet dosing necessary for many patients. However, its efficacy and safety have been barely studied.

Method: This single-center, prospective, 8-week cohort study plans to enroll 60 patients with early PD. All patients received LCE (split tablet dosing when necessary) during a 2-week titration phase followed by a 6-week maintenance phase. For the interim analysis, main endpoints included comparing Unified Parkinson’s Disease Rating Scale (UPDRS) II, III, II+III and Parkinson’s Disease Questionnaire-39 (PDQ-39) scores after 8 weeks of treatment with baseline scores. Treatment-emergent adverse events (TEAEs) were recorded.

Results: At the time of the interim analysis, 27 patients completed the study and 1 patient withdrew from the study due to back pain. Seven (25.0%) patients were treatment-naïve and received LCE only (mean maintenance Levodopa equivalent daily dose [LEDD] 256.5mg), and the other 21 patients either received LCE add-on (17) or switched to LCE (4) (mean maintenance LEDD 661.3mg vs baseline 510.3mg). Twenty-three (82.1%) patients took 1/2 tablet of LCE 100mg/25mg/200mg three times a day (tid) (Table 1). LCE treatment led to significantly improved UPDRS II (4.7 vs 7.3, P=0.010) and II+III (37.7 vs 32.7, P=0.027) scores, and insignificantly improved UPDRS III, PDQ-39 scores and H-Y stage (Figure 1A). Those patients taking 1/2 LCE tablet tid had significantly improved UPDRS II score (P=0.031) besides insignificantly improved UPDRS III, II+III, PDQ-39 scores and H-Y stage (Figure 1B), The 7 patients receiving LCE only had the same response (Figure 1C) and 6 (85.7%) of them found the treatment effective. Overall, 24 (85.7%) patients reported that the treatment was effective. Thirteen (46.4%) patients experienced at least 1 TEAE(s), most of which were mild. The most common TEAEs were chromaturia (14.3%), dizziness (14.3%) and sleepiness (7.1%) (Table 2).

Conclusion: Split tablet dosing of LCE 100mg/25mg/200mg was effective and safe in treating Chinese patients with early PD.

Demographic Data

Treatment-emergent adverse events

for patients receiving 1/2 LCE tablet tid

treatment-naïve patients who received LCE only

UPDRS II, III; H&Y; PDQ-39; LCE

References: [1] Liao X, Wu N, Liu D, Shuai B, Li S, Li K. Levodopa/carbidopa/entacapone for the treatment of early Parkinson’s disease: a meta-analysis. Neurol Sci. 2020;41:2045-2054. doi:10.1007/s10072-020-04303-x
[2] Hauser RA, Panisset M, Abbruzzese G, et al. Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson’s disease. Mov Disord. 2009;24:541-550. doi:10.1002/mds.22343
[3] Tolosa E, Hernández B, Linazasoro G, et al. Efficacy of levodopa/carbidopa/entacapone versus levodopa/carbidopa in patients with early Parkinson’s disease experiencing mild wearing-off: a randomised, double-blind trial. J Neural Transm (Vienna). 2014;121:357-366. doi:10.1007/s00702-013-1114-x

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MDS Abstracts - https://www.mdsabstracts.org/abstract/split-tablet-dosing-of-levodopa-carbidopa-entacapone-100mg-25mg-200mg-in-treating-chinese-patients-with-early-parkinsons-disease-a-single-center-prospective-cohort-study/