Hough, David
Mao, Alice R.
Aman, Michael
Lozano, Reymundo
Smith-Hicks, Constance
Martinez-Cerdeno, Veronica
Derby, Michael
Rome, Zachary
Malan, Niel
Findling, Robert L.
Clinical trials referenced in this document:
Documents that mention this clinical trial
Randomized clinical trial of low dose suramin intravenous infusions for treatment of autism spectrum disorder
https://doi.org/10.1186/s12991-023-00477-8
Funding for this research was provided by:
PaxMedica, Inc
Article History
Received: 10 March 2023
Accepted: 24 October 2023
First Online: 6 November 2023
Declarations
:
: The study was conducted at 6 sites in South Africa, where suramin is a registered medicine. The study was approved by the South African Health Products Regulatory Authority and the National Health Research Ethics Council. The study was conducted according to the ethical principles of the Declaration of Helsinki, International Conference on Harmonization guidelines for Good Clinical Practices (GCP). All subjects’ parents or guardians signed informed consent and those subjects who had capacity to do so signed assent.
: No individual patient data is contained in this manuscript. The authors will grant consent to publish these results.
: Two of the authors (Derby, Rome) are employees and hold stock in PaxMedica, Inc. Drs. Hough, Mao, Aman, Lozano, Martinez-Cerdeno, and Findling are paid scientific consultants. Dr. Smith-Hicks receives research support from the Kennedy Krieger Institute, which has an institutional agreement with PaxMedica, Inc. Dr Malan was the lead South African investigator for the study and was compensated for his clinical trial services. Dr Aman has recently consulted for Johnson & Johnson, Ovid Therapeutics, Otsuka Pharmaceuticals, Supernus Pharmaceuticals, Zynerba, and Children’s Hospital of Cincinnati. He receives royalties from Slossen Educational Publications. Dr. Findling receives or has received research support, acted as a consultant and/or has received honoraria from Abbvie, Acadia, Adamas, Afecta, Ajna, Akili, Alkermes, Allergan, American Academy of Child & Adolescent Psychiatry, American Psychiatric Press, Arbor, Axsome, BioXcel, Idorsia, Intracellular Therapies, Iqvia, Karuna, Lundbeck, Medavante Prophase, Merck, MJH Life Sciences, Neurim, NIH, Novartis, Otsuka, Oxford University Press, PaxMedica, PCORI, Pfizer, Physicians’ Postgraduate Press, Radius, Receptor Life Sciences, Sage, Signant Health, Sumitomo Pharma, Sunovion, Supernus Pharmaceuticals, Syneos, Takeda, Tris, and Viatris.