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NCT06866275 · ClinicalTrials.gov registry record · Phase 2
Suramin for the Treatment of Autism Trial: KZ101 in a Male Pediatric Population With Autism Spectrum Disorder (ASD)
A Phase 2 study of Autism Spectrum Disorder (ASD), sponsored by Children's Hospital of Orange County.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 3
- Study locations
NCT06866275: Recruiting Phase 2 study of Autism Spectrum Disorder (ASD), sponsored by Children's Hospital of Orange County.
NCT06866275 is a Phase 2 study of Autism Spectrum Disorder (ASD) that is actively recruiting participants, run by Children's Hospital of Orange County. The registered enrollment target is 45 participants, below the 100-participant average among 16 other Autism Spectrum Disorder (ASD) trials with a reported enrollment target (55% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06866275, a Phase 2 study of Autism Spectrum Disorder (ASD), is actively recruiting participants, sponsored by Children's Hospital of Orange County.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 3
- Study locations
Study Summary
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. The current study, STAT-2A, will be a randomized, double-blind, crossover, 30-week study to evaluate the preliminary proof of concept, safety, and PK of suramin sodium (KZ101) with repeat dosing by IV infusion in males 5-14 years of age who have been diagnosed with ASD. The study will be conducted at approximately 3 sites contributing approximately 15 subjects per site. Total enrollment of approximately 45 subjects is planned to achieve approximately 36 participants completing the study.
Primary Outcome
The primary efficacy endpoint will be the change in standard score on the Socialization Domain of the Comprehensive Interview Form of the Vineland Adaptive Behavior Scale Third Edition (Vineland-3), which includes subdomains for coping skills, play skills, and interpersonal relation skills.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG KZ101
Study Locations (3)
Arizona
- Southwest Autism Research and Resource Center - Phoenix
California
- Children's Hospital Orange County, Thompson Autism and Neurodevelopmental Center - Orange
Maryland
- Kennedy Krieger Institute - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2025-04-09 |
| Est. Completion | 2028-04 |
| Phase | Phase 2 |
What NCT06866275 shows while recruiting
NCT06866275 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 100-participant average among 16 other Autism Spectrum Disorder (ASD) trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Autism Spectrum Disorder (ASD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06866275 reports a single indexed study location in Arizona, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT06866275 about?
NCT06866275 is a clinical study titled "Suramin for the Treatment of Autism Trial: KZ101 in a Male Pediatric Population With Autism Spectrum Disorder (ASD)". 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 sur...
What is the current status of trial NCT06866275?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2025-04-09. Estimated completion is 2028-04.
What conditions does trial NCT06866275 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder (ASD).
What interventions are being tested in trial NCT06866275?
The interventions under investigation include: Placebo (DRUG), KZ101 (DRUG).
Who is sponsoring clinical trial NCT06866275?
This trial is sponsored by Children's Hospital of Orange County, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06866275 being conducted?
This trial has 3 study locations across Arizona, California, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06866275's enrollment target sits among peer trials
45 9th of 16 higher than 8 of 16 other Autism Spectrum Disorder (ASD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder (ASD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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