Using Suramin to Treat Autism in Boys Aged 5-14

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of suramin sodium (KZ101) in treating Autism Spectrum Disorder (ASD) in male children aged 5 to 14. The study is designed as a randomized, double-blind, crossover trial, where participants will receive either the active treatment or a placebo in two separate 8-week periods, with a washout phase in between. The trial aims to assess the preliminary proof of concept, safety, and pharmacokinetics of suramin through intravenous infusions. Approximately 45 subjects will be enrolled across three sites, with the goal of completing the study with around 36 participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

\- Subject must meet all of the following criteria to be enrolled in this study.

1. Male, aged 5-14 years
2. Clinical diagnosis of ASD by DSM-5 criteria
3. ADOS-2 ≥ 7 on the comparison score for Modules 2-4 (completed within the last 2 years).
4. CGI-S ≥ 4 for socialization specific symptoms of ASD
5. Leiter-3 non-verbal IQ \> 70
6. Standard score \< 75 on the Socialization Domain of the Comprehensive Interview Form of the Vineland Adaptive Behavior Scale Third Edition
7. Subjects who are sexually active or potentially sexually active agree to use condoms with a spermicidal as a barrier method of contraception during the treatment period and for at least 30 days after the last dose of study medication
8. Subjects agree to wear sunscreen and to wear skin covering to the maximal degree tolerated by the child for the duration of the treatment period and for at least 30 days after the last dose of study medication
9. Subjects must have a ≤ 90 minutes car ride from the study site
10. English-speaking child and parent/guardian or caregiver
11. Parent or their legal guardians must be willing to sign informed consent

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from the study.

  1. ASD diagnosis with underlying syndromic diagnosis (e.g., Fragile X, Angelman, Down's Syndrome, etc.)
  2. ≤ 5th percentile for weight
  3. Unable to tolerate venipuncture or urine collection
  4. Acute infection (e.g., upper respiratory tract infection, common cold, flu, strep, COVID-19)
  5. Severe co-morbid conditions (e.g., psychosis, seizures/epilepsy uncontrolled by medication, presence of severe visual or hearing impairment) that may interact with study procedures. Controlled epilepsy is allowed providing there has not been a breakthrough seizure in the past year.
  6. Any organ system dysfunction, especially liver (e.g., ALT or AST ≥ 1.5x the upper limit of normal), kidney (estimated glomerular filtration rate or eGFR \< 90 mL/min/1.73 m2; hematuria confirmed by urine microscopy \[ \> 5 red blood cells/high power field\]; proteinuria \[\> 1+ that does not resolve on repeat testing or urine protein to creatinine ratio \> 0.3\]; and/or presence of any granular, mixed cellular, red blood cell, white blood cell, or muddy brown casts on urine microscopy), or clinically relevant heart or adrenal abnormalities
  7. Hospitalization within the previous 2 months from screening
  8. Initiation or change in pharmacotherapy within previous 2 months from screening
  9. Initiation or change in psychosocial interventions (formal behavioral, cognitive, or cognitive-behavior therapy) within previous 2 months from screening
  10. Plan to initiate or change pharmacotherapy or psychosocial interventions during the study
  11. Taking prescription medication that may interact adversely with KZ101 or expose the subject to increased risk of harm such as medications with plasma bound substances including sulfonamides, chlorpromazine, and anti-coagulants
  12. Currently enrolled in another clinical study or has received any investigational treatment within 30 days of screening
  13. Taking \> 3 medications addressing behavioral symptoms related to ASD (ie typical/atypical antipsychotics and alpha-adrenergic agonists) or comorbid medical conditions such as ADHD, anxiety, or depression. Anti-seizure medications and other medications not related to neurobehavioral symptoms do not count towards the total number of medications allowed.
  14. History of serious dermatological reactions
  15. History of allergy, intolerance, or photosensitivity to any drug
  16. Unable or unwilling to adhere to study requirements

Where it's running

• Children's Hospital Orange County, Thompson Autism and Neurodevelopmental Center
  Orange, California, United States Recruiting
• Kennedy Krieger Institute
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Aram Kim, MD — Thompson Autism and Neurodevelopmental Center, Children's Hospital of Orange County
• Study coordinator: Adrienne Moore, PhD
• Email: adrienne.moore@choc.org
• Phone: 714-288-7456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.