Evidence map›Paper›PMID 37932739›Full record

ArticleAnnals of general psychiatry2023

Randomized clinical trial of low dose suramin intravenous infusions for treatment of autism spectrum disorder.

David Hough, Alice R Mao, Michael Aman, Reymundo Lozano, Constance Smith-Hicks, Veronica Martinez-Cerdeno, Michael Derby, Zachary Rome, Niel Malan, Robert L Findling

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Annals of general psychiatry, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06058962 (A Three-Arm, Prospective, Randomized, Double Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of 2 Doses of Suramin vs. Placebo in Male Children With ASD Receiving Standard Treatment), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.2field-weighted citation impact, top 11% 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.

NCT06058962 phase2completednot on this map

A Three-Arm, Prospective, Randomized, Double Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of 2 Doses of Suramin vs. Placebo in Male Children With ASD Receiving Standard Treatment

TypeinterventionalSponsorPaxmedicaRan2019 to 2021Enrolled52ConditionsAutism Spectrum DisorderArmsSuramin Sodium
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 7 citations in OpenAlex.

  1. Journal of medicinal chemistry · 2026
    Article
  2. Review
  3. Article
  4. Novel therapeutics in autism spectrum disorder.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  5. Article
  6. Review
  7. Article
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

10 authors at 7 institutions in 1 country.

David HoughPaxMedica, Inc, sponsor of the study, 303 S Broadway, Suite 125, Tarrytown, NY, 10591, USA. psychsvcprince@gmail.com.
Alice R MaoPsychiatry and Behavioral Sciences, Baylor College of Medicine and PaxMedica, Inc., Houston, Texas, USA.
Michael AmanO.S.U. Research Unit on Pediatric Psychopharmacology (RUPP), Research, Nisonger Center at The Ohio State University, Columbus, Ohio, USA.
Reymundo LozanoGenetics and Genomics Sciences, Psychiatry and Pediatrics, Icahn School of Medicine, Mount Sinai, New York, NY, USA.
Constance Smith-HicksNeurology, Kennedy Krieger Institute, Johns Hopkins Univ School of Medicine, Baltimore, MD, USA.
Veronica Martinez-CerdenoPathology and Laboratory Medicine, Anatomy of Autism and FXS laboratory, Institute for Pediatric Regenerative Medicine, Shriners Hospital of Northern California, and UCD MIND Institute. Pathology Director of the FXS & FXTAS brain repository at UCD, University of California Davis School of Medicine, Davis, California, USA.
Michael DerbyTardimed Sciences LLC., PaxMedica, Inc., Tarrytown, New York, USA.
Zachary RomePaxMedica, Inc., Tarrytown, New York, USA.
Niel MalanPhoenix Pharma LTD, 2 Eastbourne Rd, Mt Croix, Port Elizabeth, South Africa.
Robert L FindlingChair, Department of Psychiatry, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.
Baylor College of Medicine · USKennedy Krieger Institute · USMount Sinai Hospital · USPsychogenics (United States) · USShriners Hospitals for Children - Erie · USThe Ohio State University · USVirginia Commonwealth University · US

Funding

Sleep and Circadian Dysfunction, Brain and Neurobehavioral Development in AutismP50HD103538 · NICHD · HUGO W. MOSER RES INST KENNEDY KRIEGER · PI S. Ali Fatemi, Bradley L Schlaggar · 2020 to 2026
$9.9M
NICHD NIH HHS P50 HD103538
6 · The paper itself

Abstract

backgroundThere is a critical need for effective treatment of the core symptoms of autism spectrum disorder (ASD). The purinergic antagonist suramin may improve core symptoms through restoration of normal mitochondrial function and reduction of neuro-inflammation via its known antagonism of P2X and P2Y receptors. Nonclinical studies in fragile X knockout mice and the maternal immune activation model support these hypotheses.

methodsWe conducted a 14 week, randomized, double-blind, placebo-controlled proof -of-concept study (N = 52) to test the efficacy and safety of suramin intravenous infusions in boys aged 4-15 years with moderate to severe ASD. The study had 3 treatment arms: 10 mg/kg suramin, 20 mg/kg suramin, and placebo given at baseline, week 4, and week 8. The Aberrant Behavior Checklist of Core Symptoms (ABC-Core) (subscales 2, 3, and 5) was the primary endpoint and the Clinical Global Impressions-Improvement (CGI-I) was a secondary endpoint.

resultsForty-four subjects completed the study. The 10 mg/kg suramin group showed a greater, but statistically non-significant, numeric improvement (- 12.5 ± 3.18 [mean ± SE]) vs. placebo (- 8.9 ± 2.86) in ABC-Core at Week 14. The 20 mg/kg suramin group did not show improvement over placebo. In exploratory analyses, the 10 mg/kg arm showed greater ABC Core differences from placebo in younger subjects and among those with less severe symptoms. In CGI-I, the 10 mg/kg arm showed a statistically significant improvement from baseline (2.8 ± 0.30 [mean ± SE]) compared to placebo (1.7 ± 0.27) (p = 0.016). The 20 mg/kg arm had a 2.0 ± 0.28 improvement in CGI-I, which was not statistically significant compared to placebo (p = 0.65).

conclusionSuramin was generally safe and well tolerated over 14 weeks; most adverse events were mild to moderate in severity. Trial Registration Registered with the South African Health Authority, registration number DOH-27-0419-6116. CLINICALTRIALS: Gov registration ID is NCT06058962, last update posted 2023-09-28.

Indexed as

Autism spectrum disorderPurinergic receptor antagonistSuramin

Identifiers

PMID37932739
PMCPMC10626700
OpenAlexW4388416797

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.