Status:
COMPLETED
Double Blind Trial in Children With Autism Spectrum Disorder
Lead Sponsor:
Paxmedica
Conditions:
Autism Spectrum Disorder
Eligibility:
MALE
4-17 years
Phase:
PHASE2
Brief Summary
This study investigated the safe and efficacious use of suramin as a novel treatment for ASD by testing two suramin doses vs placebo
Detailed Description
PUR-ONQ-ASD-001 was a multicenter, 3-arm, prospective, randomized, double blind, placebo-controlled multiple dose trial involving 2 dose levels of suramin vs. placebo. The study randomized 52 male par...
Eligibility Criteria
Inclusion
- Male children aged 4 - 17 years
- Participants with or without treatment interventions for ASD
- Participants must have been diagnosed with ASD by Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V)
- Autism diagnostic observation schedule, version 2 (ADOS-2) Comparison scores in the
- moderate and high level as evaluated on the ADOS-2
- Stable treatment intervention for ≥ 2 months
- Participants agreed to not change their treatment interventions throughout the study
- duration
- Participants on Ritalin and Risperdal or similar medication agreed to not change their
- dose during the study
Exclusion
- Hospitalization within the previous 2 months
- An acute medical problem, Rett syndrome, microcephaly, tuberous sclerosis, neurofibromatosis, epilepsy, or clinically significant liver, kidney, or adrenal disease or persons suffering from any serious acute condition where, in the investigator's opinion, the participant's well-being may have been compromised
- Planning to start a new drug, diet, or behavioral intervention during the study
- Weight under the 5th percentile for age
- Unable to tolerate venipuncture, urine collection, or an indwelling IV catheter for 3-4 hours
- Plasma creatinine above normal for age and weight according to the laboratory reference ranges.
- Liver function alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5-fold above the upper limit of normal
- Known intolerance to suramin or other antipurinergic drugs
- Unable to perform or cooperate with study requirements
- Children with known syndromic forms of ASD caused by DNA mutation or chromosomal copy number variation
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06058962
Start Date
June 1 2019
End Date
March 15 2021
Last Update
November 13 2023
Active Locations (1)
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1
PaxMedica
Tarrytown, New York, United States, 10591