EAN 2025 | The OASIS trial: the effects of opicapone on sleep disturbances in Parkinson’s disease

Sleep problems are frequent in patients with Parkinson’s disease and they also impact on quality of life and on the health status of patients. In fact, in clinical practice we use, you know, as treatment strategies, clonazepam or melatonin for insomnia and also for RBD. But in fact, we don’t have clinical trials supporting its use, so it’s clearly a relevant problem for which we have weak data in terms of clinical trials. The OASIS trial evaluated the efficacy of opicapone for the management of sleep disorders in patients with Parkinson’s disease and motor fluctuation. It was a single arm trial, so without a control group, and we evaluated baseline with four weeks after four weeks of treatment. In fact, using the PDSS2 scale, there was a benefit. So clearly, patients after being treated with opicapone were better. The magnitude of the effect was above what we know is the minimal clinical relevant difference for that scale in Parkinson’s disease patients with sleep problems. So the magnitude clearly seems to be relevant. And also, when we analyze in more detail the results using that scale, we see that there is a benefit. I would say in the motor aspects that we associate with sleep in Parkinson’s disease, but also with some aspects related with, you know, sleep complaints that are not mandatorily related with motor. So there may be an effect that it’s motor related, but also we cannot exclude, there may be also again in sleep that are not just because, you know, the akinesia during the night may be improved. Because this is a weak field, I would say that any data that came from a clinical trial, even if it is a single arm trial, brings important information for the management of sleep in Parkinson’s disease patients.

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