Evidence map›Paper›PMID 30534585›Full record

ArticleNPJ Parkinson's disease2018

Safety and tolerability of IRL790 in Parkinson's disease with levodopa-induced dyskinesia-a phase 1b trial.

Per Svenningsson, Anders Johansson, Dag Nyholm, Panagiota Tsitsi, Fredrik Hansson, Clas Sonesson, Joakim Tedroff

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in NPJ Parkinson's disease, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04435431 (A Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily ON-time Without Troublesome Dyskinesia in Patients With Parkinson's Disease), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.5field-weighted citation impact, top 18% of its field
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.

NCT04435431 phase2completednot on this mapstarted 2020, after this paper: background citation

A Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily ON-time Without Troublesome Dyskinesia in Patients With Parkinson's Disease

TypeinterventionalSponsorIntegrative Research Laboratories ABRan2020 to 2022Enrolled155ConditionsParkinson DiseaseArmsMesdopetam, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 22 citations in OpenAlex.

  1. NLX-112 Randomized Phase 2A Trial: Safety, Tolerability, Anti-Dyskinetic, and Anti-Parkinsonian Efficacy.Movement disorders : official journal of the Movement Disorder Society · 2025
    Trial
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Neurophysiological treatment effects of mesdopetam, pimavanserin and clozapine in a rodent model of Parkinson's disease psychosis.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2024
    Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. 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

7 authors at 3 institutions in 1 country.

Per Svenningsson1Department of Clinical Neuroscience, Karolinska Institutet, 171 77 Stockholm, Sweden.
Anders Johansson1Department of Clinical Neuroscience, Karolinska Institutet, 171 77 Stockholm, Sweden.
Dag Nyholm3Department of Neuroscience, Neurology, Uppsala University, 751 85 Uppsala, Sweden.
Panagiota Tsitsi1Department of Clinical Neuroscience, Karolinska Institutet, 171 77 Stockholm, Sweden.
Fredrik HanssonClinical Trial Consultants, Dag Hammarskjöldsväg 13, 752 37 Uppsala, Sweden.
Clas SonessonIntegrative Research Laboratories AB, Arvid Wallgrens backe 20, 413 46 Göteborg, Sweden.
Joakim Tedroff1Department of Clinical Neuroscience, Karolinska Institutet, 171 77 Stockholm, Sweden.
Karolinska Institutet · SEIntegrative Research Laboratories · SEUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

IRL790 is a novel compound with psychomotor stabilizing properties primarily targeting the dopamine D3 receptor. IRL790 is developed as an experimental treatment for levodopa-induced dyskinesia (LID), impulse control disorder, and psychosis in Parkinson's disease (PD). The primary objective was to investigate the safety and tolerability of IRL790 in PD patients with LID in a randomized controlled trial. PD patients with peak-dose dyskinesia were randomized to placebo or IRL790 treatment (1:3 ratio) for 4 weeks. Study drug was given as an adjunct treatment to the patients' regular stable antiparkinsonian medication. Dosing was individually titrated for 14 days, whereafter dosing was kept stable for an additional 14 days. Fifteen patients were randomized to treatment and 13 patients completed the 4-week treatment. Adverse events were mostly reported during the titration phase of the trial. They were mainly central nervous system related and could be mitigated by dose adjustments. There were no serious adverse events. There were no clinically significant changes in vital signs, electrocardiogram, and laboratory parameters due to the treatment. The average dose in the stable dose phase was 18 mg daily, yielding a 2-h post-dose plasma concentration of average 229 nM on day 28. Assessments for motor function showed a numeric reduction in dyskinesia. It is concluded that IRL790 can be safely administered to patients with advanced PD. The results will be of guidance for the design of phase 2 studies.

Identifiers

PMID30534585
PMCPMC6283839
OpenAlexW2902036449

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.