Patterns of Daily Motor-Symptom Control with Carbidopa/Levodopa Enteral Suspension Versus Oral Carbidopa/Levodopa Therapy in Advanced Parkinson's Disease: Clinical Trial Post Hoc Analyses.

Abstract

IntroductionA clinical trial in advanced Parkinson’s disease (APD) has established the superiority of carbidopa/levodopa enteral suspension (CLES) in reducing total patient “off” time (OFF) and increasing total “on” time without troublesome dyskinesia (ON-woTD) over orally administered immediate-release carbidopa/levodopa tablets (IR–CL). However, temporal patterns of these improvements throughout the waking day have not been examined. In this analysis, time to ON-woTD after waking and patterns of motor-symptom control throughout the waking day were compared between CLES and IR–CL.MethodsPost hoc analyses of APD patient-diary data from the phase 3 randomized controlled trial were used to compare changes in time to ON-woTD after waking, motor-symptom control throughout the waking day, occurrence of extreme fluctuations between OFF and “on” with troublesome dyskinesia, and motor-state transitions with CLES versus IR–CL from baseline to week 12.ResultsThe sample included 33 CLES-treated and 30 IR–CL-treated patients. Among the CLES group, the percentage of patient days achieving ON-woTD within 30 min of waking was three times higher at week 12 versus baseline (33% vs. 11%, p = 0.0043); no significant change occurred with IR–CL. When the waking day was divided into four 4-h periods, CLES versus IR–CL treatment produced significantly greater reductions in OFF during three periods, and two periods had increased ON-woTD. Fewer CLES-treated patients had extreme fluctuations at week 12 (3% vs. 23%, p = 0.0224) compared to IR–CL-treated patients. From baseline to week 12, CLES-treated patients had greater reductions in the average number of motor-state transitions compared to IR–CL-treated patients (− 1.6, p = 0.0295).ConclusionCLES-treated patients experienced a more rapid onset of ON-woTD after waking and greater consistency of ON-woTD throughout their waking day than IR–CL-treated patients.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40120-022-00332-0.