Improvements in mean total amount of time and percentage of participants that were awake suggested limited effect with opicapone (Ogentys; Neurocrine Bio).
A pooled analysis of patients with Parkinson disease (PD) from the BIPARK I and II studies (NCT015668073; NCT91227655) revealed a modest positive benefit when treated with opicapone (Ogentys; Neurocrine Bio) 50-mg once-daily as an add-on to current levodopa/carbidopa regimen, although the data was limited by small sample sizes. The findings were presented at the International Parkinson and Movement Disorder Society (MDS) Virtual Congress 2021, September 17-22, by Robert A. Hauser, MD, director, Parkinson’s and Movement Disorders Center, University of Southern Florida.1
Investigators assessed the effects of opicapone, a selective catechol-O-methyltransferase inhibitor, in a pooled population of individuals with PD who had at least 1 awakening after falling asleep, based on 24-hour patient diaries. These post-hoc analyses evaluated outcomes such as number of times that participants awake after sleep onset in an OFF episode, total awake time after sleep onset (WASO), and percent of sleep time spent awake.
The dataset included 522 patients (opicapone, n = 265; placebo, n = 257) with PD with motor fluctuations. These patients had mean motor fluctuation duration of over 2.5 years and a mean daily OFF time over 6 hours. Among the total cohort, 14.8% (opicapone, 50 [18.9%]; placebo, 27 [10.5%]) woke up after sleep onset and 79.2% (61 of 77) of these participants woke up in an OFF episode.
Although the effects were modest, there was a decreased frequency of awakenings at week 14/15, or the conclusion of the study, in those treated with opicapone, but not in those who received placebo (mean change from baseline: opicapone, –0.9; placebo, 0.1). Additional modest improvements were observed for opicapone, but not placebo, on percent of participants that were awake (WASO duration: opicapone, –0.5; placebo, 0.2). Lastly, investigators observed similar effects on change in percent time awake after falling asleep (opicapone, –9.0%; placebo, 2.0%). Hauser and colleagues concluded that “more research is needed to better understand the effects of opicapone on sleep in patients with PD who are experiencing motor fluctuations.”
In April 2020, opicapone received FDA approval as a once-daily adjunctive treatment of OFF episodes in patients with PD.2 The US approval was supported by 38 clinical studies of more than 1000 patients, and included both phase 3 BIPARK studies.
Results of BIPARK-1 revealed a placebo-adjusted OFF time reduction of 60.8 minutes in the 50-mg group, a 51% reduction that was observed in the active comparator group (40.3 minutes).3 BIPARK-2 included 427 patients with PD and motor fluctuations and showed that treatment with 50-mg opicapone had a significant 54.3-minute reduction in OFF time versus placebo, with daily OFF time reduced by 126.3 minutes over 1-year follow-up.4
NeurologyLive sat down with Joaquim J. Ferreira, MD, PhD, at the 2020 MDS Virtual Congress to discuss data he and his colleagues presented on a post-hoc analysis of the BIPARK I and II trials. Watch his commentary below, as he provides his perspective on what the clinical community should be aware of regarding their analyses.