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New treatment option for Autism Spectrum Disorder (ASD)
Official title Suramin for the Treatment of Autism Trial: KZ101 in a Male Pediatric Population With Autism Spectrum Disorder (ASD)
ClinicalTrials.gov ID: NCT06866275
What this study is testing
What is KZ101?
KZ101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for autism spectrum disorder (asd).
Also referred to as Suramin, Suramin sodium.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Suramin has been found to correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic and environmental mouse models of autism. A preliminary clinical trial (SAT-1) examined the safety and activity of a single low-dose of suramin in children with ASD and concluded suramin showed promise as a novel approach to treatment of ASD.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 14, men only
You may be able to join if
- \- Subject must meet all of the following criteria to be enrolled in this study.
- Male, aged 5-14 years
- Clinical diagnosis of ASD by DSM-5 criteria
- ADOS-2 ≥ 7 on the comparison score for Modules 2-4 (completed within the last 2 years).
- CGI-S ≥ 4 for socialization specific symptoms of ASD
You likely can't join if
- people who meet any of the following criteria will be excluded from the study.
- ASD diagnosis with underlying syndromic diagnosis (e.g., Fragile X, Angelman, Down's Syndrome, etc.)
- ≤ 5th percentile for weight
- Unable to tolerate venipuncture or urine collection
- Acute infection (e.g., upper respiratory tract infection, common cold, flu, strep, COVID-19)
- Severe co-morbid conditions (e.g., psychosis, seizures/epilepsy uncontrolled by medication, presence of severe visual or hearing impairment) that may...
See the full eligibility criteria
- \- Subject must meet all of the following criteria to be enrolled in this study.
- Male, aged 5-14 years
- Clinical diagnosis of ASD by DSM-5 criteria
- ADOS-2 ≥ 7 on the comparison score for Modules 2-4 (completed within the last 2 years).
- CGI-S ≥ 4 for socialization specific symptoms of ASD
- Leiter-3 non-verbal IQ \> 70
- Standard score \< 75 on the Socialization Domain of the Comprehensive Interview Form of the Vineland Adaptive Behavior Scale Third Edition
- people 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...
- people 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
- people must have a ≤ 90 minutes car ride from the study site
- English-speaking child and parent/guardian or caregiver
- Parent or their legal guardians must be willing to sign informed consent
- people who meet any of the following criteria will be excluded from the study.
- ASD diagnosis with underlying syndromic diagnosis (e.g., Fragile X, Angelman, Down's Syndrome, etc.)
- ≤ 5th percentile for weight
- Unable to tolerate venipuncture or urine collection
- Acute infection (e.g., upper respiratory tract infection, common cold, flu, strep, COVID-19)
- 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...
- 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 \ 5 red blood cells/high power field]; proteinuria [\> 1+ that...
- Hospitalization within the previous 2 months from screening
- Initiation or change in pharmacotherapy within previous 2 months from screening
- Initiation or change in psychosocial interventions (formal behavioral, cognitive, or cognitive-behavior therapy) within previous 2 months from screening
- Plan to initiate or change pharmacotherapy or psychosocial interventions during the study
- 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...
- Currently enrolled in another clinical study or has received any investigational treatment within 30 days of screening
- 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...
- History of serious dermatological reactions
- History of allergy, intolerance, or photosensitivity to any drug
- Unable or unwilling to adhere to study requirements
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Orange, California, United States
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 5 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Orange, California, United States; Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.