Opicapone to Treat Early Wearing-off in Parkinson's Disease Patients: The Korean ADOPTION Trialopen access
- Authors
- Lee, Jee-Young; Ma, Hyeo-il; Ferreira, Joaquim J.; Rocha, Jose-Francisco; Sung, Young Hee; Song, In-Uk; Ahn, Tae-Beom; Kwon, Do Young; Cheon, Sang-Myung; Kim, Jong-Min; Lee, Chong Sik; Lee, Phil Hyu; Park, Jeong-Ho; Lee, Jae-Hyeok; Park, Mee Young; Kim, Sang Jin; Baik, Jong Sam; Choi, Seong-Min; Shin, Hae-Won; Lee, Ho-Won; Kang, Suk Yun; Jeon, Beomseok
- Issue Date
- Jun-2024
- Publisher
- WILEY
- Keywords
- levodopa; opicapone; Parkinson's disease; wearing off
- Citation
- MOVEMENT DISORDERS CLINICAL PRACTICE, v.11, no.6, pp 655 - 665
- Pages
- 11
- Journal Title
- MOVEMENT DISORDERS CLINICAL PRACTICE
- Volume
- 11
- Number
- 6
- Start Page
- 655
- End Page
- 665
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/91509
- DOI
- 10.1002/mdc3.14030
- ISSN
- 2330-1619
- Abstract
- Background: Increasing levodopa (L-dopa)/dopa decarboxylase inhibitor (DDCI) daily dose or adding a catechol-O-methyltransferase (COMT) inhibitor to levodopa/DDCI therapy are strategies used to manage wearing-off symptoms in Parkinson's disease (PD) patients. ObjectivesTo evaluate the COMT inhibitor opicapone versus an additional dose of levodopa to treat early wearing-off in PD patients. Methods: ADOPTION was a randomized, parallel-group, open-label, Phase 4 study conducted in Korea. At baseline, eligible patients were randomized (1:1) to opicapone 50 mg (n = 87) or L-dopa 100 mg (n = 81) (added to current L-dopa/DDCI therapy) for 4 weeks. The main efficacy endpoint was change from baseline to end of study in absolute off time. Other endpoints included changes in on time, in Movement Disorder Society-Unified Parkinson's Disease Rating Scale and 8-item PD Questionnaire scores, and the Clinical and Patient Global Impression of Improvement/Change. Results: The adjusted mean in absolute off time was significantly greater for opicapone 50 mg than for L-dopa 100 mg (-62.1 vs. -16.7 minutes; P = 0.0015). Opicapone-treated patients also reported a greater reduction in the percentage of off time (P = 0.0015), a greater increase in absolute on time (P = 0.0338) and a greater increase in the percentage of on time (P = 0.0015). There were no significant differences in other secondary endpoints. The L-dopa equivalent daily dose was significantly higher in the opicapone group (750.9 vs. 690.0 mg; P = 0.0247), when a 0.5 conversion factor is applied. Conclusions: Opicapone 50 mg was more effective than an additional 100 mg L-dopa dose at decreasing off time in patients with PD and early wearing-off.
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