EAN 2025 | EPSILON trial: 1.5-year follow-up of opicapone in non-fluctuating Parkinson’s disease

This is a very interesting trial to be discussed because what we have evaluated was the efficacy of use of opicapone that it’s a new COMT inhibitor for the management of Parkinson’s disease patients but patients without motor fluctuations. Opicapone is a COMT inhibitor and COMT inhibitors are licensed for the management of Parkinson’s patients with motor fluctuation and its use in patients without motor fluctuations, it’s an off-label use. I would say it’s a hypothesis that has already been studied with entacapone and with tolcapone, but this is the first trial using opicapone. In this trial, we have evaluated if opicapone adjuvant to levodopa compared with placebo would generate an increase in terms of improvement of motor impairment using the MDS-UPDRS Part 3 as the primary outcome and in fact after six months of follow-up the trial is positive. So, opicapone adjuvant to levodopa is more efficacious than adding placebo for the patients without motor fluctuations. What I have shared again in this Congress was also the extension, the results of the extension period and the results are very interesting not just because they document that the risk that we were in some way anticipated of aggravating motor fluctuations and dyskinesia by the use of a COMT inhibitor adjuvant to levodopa, again, did not occur. In fact, the patients that were initially treated with placebo had more frequent reported dyskinesia and motor fluctuations, and after one year, so patients had one year and a half of follow-up, not just the patients that started on opicapone first were still better in motor terms, but also, they had less dyskinesia and less motor fluctuation. This is in some way, it’s a very important information because it brings, it opens the hypothesis that using COMT inhibitors early, even in patients without motor fluctuation, not just generate the gain in terms of, you know, improving motor impairment, but also the hypothetical risk to aggravate dyskinesia and motor fluctuation need to be reassessed. And clearly this is something that at least after one year and a half, we did not find. So the safety and tolerability profile seems to be much better than what was anticipated.

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