Evidence map›Paper›PMID 40091754›Full record

Trial reportMovement disorders : official journal of the Movement Disorder Society2025

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

Per Svenningsson, Per Odin, Filip Bergquist, Karin Wirdefeldt, Dag Nyholm, Mattias Andréasson, Ioanna Markaki, Anders C Johansson, Måns Jergil, Christopher Jankosky and 4 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Movement disorders : official journal of the Movement Disorder Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Review
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  6. Article
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  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Per SvenningssonASC Torsplan, Stockholm, Sweden.ORCID 0000-0001-6727-3802
Per OdinDepartment of Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden.
Filip BergquistSahlgrenska Hospital, Gothenburg, Sweden.ORCID 0000-0002-3437-0267
Karin WirdefeldtDepartment of Neurology, Karolinska University Hospital, Solna, Sweden.
Dag NyholmUppsala University, Uppsala, Sweden.ORCID 0000-0001-9776-7715
Mattias AndréassonASC Torsplan, Stockholm, Sweden.
Ioanna MarkakiASC Torsplan, Stockholm, Sweden.ORCID 0000-0003-3328-5746
Anders C JohanssonDepartment of Neurology, Karolinska University Hospital, Solna, Sweden.
Måns JergilClinical Trial Consultants, AB, Uppsala, Sweden.
Christopher JankoskyNeurolixis Inc., Park Ridge, New Jersey, USA.
Mark A VarneyNeurolixis Inc., Park Ridge, New Jersey, USA.
Fabienne HerbrechtNeurolixis SAS, Castres, France.
Steven A JohnsonNeurolixis Inc., Park Ridge, New Jersey, USA.
Adrian Newman-TancrediNeurolixis SAS, Castres, France.

Funding

Michael J. Fox Foundation for Parkinson's Research MJFF- 019508Parkinson's UK DYS-20-02
6 · The paper itself

Abstract

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-HT

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.

Indexed as

Antiparkinson AgentsDyskinesia, Drug-InducedLevodopaParkinson DiseaseSerotonin 5-HT1 Receptor AgonistsAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAntiparkinson AgentsLevodopaSerotonin 5-HT1 Receptor Agonists5‐HT1A receptordyskinesialevodopaNLX‐112Parkinson's diseaseserotonin

Identifiers

PMID40091754
PMCPMC12160962

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.