NLX-112 Randomize Faz 2A Denemesi: Güvenlik, Tolerabilite, Anti-Diskinetik ve Anti-Parkinsoncu Etkinlik.

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BackgroundLevodopa-induced dyskinesia (LID) in Parkinson's disease (PD) is associated with 'false neurotransmitter' release of dopamine from serotonin (5-HT) neurons. NLX-112 is a first-in-class, highly selective 5-HT1A receptor agonist which counteracts LIDs in experimental PD models.ObjectivesThe primary objective was to evaluate the safety and tolerability of NLX-112 compared with placebo in people with PD. The secondary objective was to assess the preliminary efficacy of NLX-112 in reducing LID and its effects on PD symptoms.MethodsParticipants received NLX-112 or placebo (2:1 ratio) alongside stable Parkinson's medications, with 22 participants completing the study. Dosing was up-titrated over 28 days to 2 mg/day (1 mg twice daily), stabilized for 14 days (to day 42), and down-titrated for 14 days. Efficacy was measured using the Unified Dyskinesia Rating Scale (UDysRS), Unified Parkinson's Disease Rating Scale (UPDRS), and Clinical Global Impression of Change (CGI-C) following a levodopa challenge (150% of usual dose).ResultsAdverse events (AEs) were mainly central nervous system (CNS)-related and mostly occurred during up-titration, with no serious AEs in the NLX-112 group. There were no treatment-induced clinically significant changes in vital signs, electrocardiogram, or laboratory parameters. NLX-112 reduced LID from baseline levels: at day 42, UDysRS total score decreased by 6.3 points, whereas placebo group changes were not significant (-2.4). NLX-112 also reduced parkinsonism from baseline values: UPDRS Part 3 scores decreased by 3.7 points, whereas placebo group changes were non-significant (+0.1). In CGI-C assessment, the NLX-112 group showed greater improvement than the placebo group (53% vs. 29%).ConclusionThese results support further clinical investigation of NLX-112 for treatment of PD LID. © 2025 Neurolixis SAS. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

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