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Clinical Trial
. 2024 Jun;11(6):655-665.
doi: 10.1002/mdc3.14030. Epub 2024 Apr 9.

Opicapone to Treat Early Wearing-off in Parkinson's Disease Patients: The Korean ADOPTION Trial

Jee-Young Lee  1 , Hyeo-Il Ma  2 , Joaquim J Ferreira  3   4 , José-Francisco Rocha  5 , Young Hee Sung  6 , In-Uk Song  7 , Tae-Beom Ahn  8 , Do Young Kwon  9 , Sang-Myung Cheon  10 , Jong-Min Kim  11 , Chong Sik Lee  12 , Phil Hyu Lee  13 , Jeong-Ho Park  14 , Jae-Hyeok Lee  15 , Mee Young Park  16 , Sang Jin Kim  17 , Jong Sam Baik  18 , Seong-Min Choi  19 , Hae-Won Shin  20 , Ho-Won Lee  21 , Suk Yun Kang  22 , Beomseok Jeon  23
Affiliations
Clinical Trial

Opicapone to Treat Early Wearing-off in Parkinson's Disease Patients: The Korean ADOPTION Trial

Jee-Young Lee et al. Mov Disord Clin Pract. 2024 Jun.

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.

Objectives: To 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.

Keywords: Parkinson's disease; levodopa; opicapone; wearing off.

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Figures

Figure 1
Figure 1
Adjusted mean (SE) change from baseline to end of study treatment in the full analysis set in A: absolute off time. B: absolute on time. C: absolute on time without dyskinesia. L‐dopa, levodopa; SE standard error.
Figure 2
Figure 2
Results in the opicapone 50 mg group and L‐dopa 100 mg group in the full analysis set for A: the Clinical Global Impression of Improvement. B: the Patient Global Impression of Change. L‐dopa, levodopa.
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