NCT04278898 Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose
| NCT ID | NCT04278898 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stanford University |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2021-02-12 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2021-02-12 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using N-acetylcysteine (NAC), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. The findings from this research will shed light on the mechanisms of action underlying the clinical benefits of NAC.
Eligibility Criteria
Inclusion Criteria: * children between 3 years and 12 years 11 months at the time of consent * diagnosis of Autism Spectrum Disorder confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2), or Brief Observation of Symptoms of Autism (BOSA), or Childhood Autism Rating Scale- Second Edition (CARS-2). * at least moderate Restricted and Repetitive Behaviors severity defined by a Children's Yale-Brown Obsessive Compulsive Scale for children with autism spectrum disorder score ≥ 11, * physical development indicative of prepubescence as defined by the criteria for Tanner Stage 1, * medically stable, * passes MR safety screening (e.g., no metal in the body). Exclusion Criteria: * presence of known genetic abnormalities associated with Autism Spectrum Disorder (e.g. Fragile X), * current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia), * presence of significant medical problems that would interfere with participation, * the inability of at least one caregiver to speak/read English to a sufficient level to complete study requirements and materials, * individuals taking antioxidant agents and glutathione prodrugs, or * the inability/unwillingness to swallow an agent during the screening visit.
Contact & Investigator
John Hegarty, PhD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT04278898 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 12 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04278898 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04278898 currently recruiting?
Yes, NCT04278898 is actively recruiting participants. Contact the research team at autismresearch@stanford.edu for enrollment information.
Where is the NCT04278898 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT04278898 clinical trial?
NCT04278898 is sponsored by Stanford University. The principal investigator is John Hegarty, PhD at Stanford University. The trial plans to enroll 24 participants.