NLX-112 Randomized Phase 2A Trial: Safety, Tolerability, Anti-Dyskinetic, and Anti-Parkinsonian Efficacy.

ABSTRACT:

Background

Levodopa-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-HT_1A receptor agonist which counteracts LIDs in experimental PD models.

Objectives

The 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.

Methods

Participants 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

SUBMITTER: Svenningsson P 

PROVIDER: S-EPMC12160962 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature