Objective: To investigate the effects of the synthetic cannabinoid nabilone for the treatment of non-motor symptoms in Parkinson´s disease (PD) in a controlled fashion.

Background: Non-motor symptoms in PD are increasingly prevalent over the course of the illness and a major determinant of quality of life. We assessed efficacy and safety of nabilone, a synthetic analogue of tetrahydrocannabinol, as a treatment for non-motor symptoms in PD.

Method: This was a single-centre phase II randomised, placebo-controlled, double-blind, parallel-group, enriched enrolment randomised withdrawal trial at the university hospital Innsbruck, Austria. PD patients with stable motor disease suffering from disturbing non-motor symptoms defined by a score of ≥4 points on the MDS-UPDRS Part I underwent open-label nabilone titration (0.25mg once daily-1mg twice daily, orally, Phase1). Treatment responders were subsequently randomised using a blinded computer-generated schedule to either continue with nabilone or switch to placebo for four weeks (Phase2). All participants and study personnel were masked to treatment assignment. The primary efficacy criterion was the change of the MDS-UPDRS Part I between randomisation and week four. Safety was analysed in all patients who received at least one dose of study medication.

Results: Between October 2017 and July 2019, 48 patients received nabilone in the open-label titration part of the trial, of whom 38 continued in phase2 and nine discontinued before randomisation (drop-out=1, AEs=3, non-responder=5). Nineteen patients were assigned to nabilone and placebo, each. Mean change of MDS-UPDRS Part I at week four was 2.63 (95%CI 1.53-3.74,p=0.002, effect size=1.15) in the placebo versus 1.00 (95%CI -0.16-2.16,p=0.280, effect size=0.42) in the nabilone-group (difference: 1.63 ,95%CI 0.09-3.18,p=0.030, effect size=0.66). Similar proportions of patients in each group had adverse events (placebo-group: 42%; nabilone: 32% of the group) in the double-blind phase. There were no serious adverse events.

Conclusion: Our results highlight the potential efficacy of nabilone for patients with PD and disturbing non-motor symptoms, which appears to be driven by positive effects on anxious mood and night-time sleep problems.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/effects-of-nabilone-on-non-motor-symptoms-of-parkinsons-disease-a-randomised-placebo-controlled-study-the-nms-nab-study/