NCT05664789 Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial
| NCT ID | NCT05664789 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Stanford University |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2023-04-26 |
| Primary Completion | 2028-01-31 |
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 144 participants in total. It began in 2023-04-26 with a primary completion date of 2028-01-31.
⚠ 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 and the effects of NAC on altering restricted and repetitive behavior symptom severity in children with autism spectrum disorder. This is a 12-week double-blind, randomized, placebo-controlled trial of NAC.
Eligibility Criteria
Inclusion Criteria: * children between 3 years and 12 years 11 months * diagnosis of autism spectrum disorder confirmed with the Autism Diagnostic Interview- Revised and the Autism Diagnostic Observation Schedule-2, Brief Observation of Symptoms of Autism, or Childhood Autism Rating Scale * at least moderate severity of restricted and repetitive behaviors defined by a Children's Yale-Brown Obsessive Compulsive Scale for Autism Spectrum Disorder score ≥ 11 * physical development indicative of prepubescence as defined by criteria for Tanner Stage 1 * if home address is within 300 miles of the primary study site, participants must pass MR safety screening (e.g., no metal in the body) and attempt baseline neuroimaging (MRI or EEG), otherwise baseline neuroimaging is not required for participation * have stable medication regimens (≥ 30 days) and psychosocial treatments (≥ 60 days) prior to randomization with no anticipated changes during the trial Exclusion Criteria: * presence of known ge
Frequently Asked Questions
Who can join the NCT05664789 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 NCT05664789 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 NCT05664789 currently recruiting?
Yes, NCT05664789 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stanford University to inquire about joining.
Where is the NCT05664789 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT05664789 clinical trial?
NCT05664789 is sponsored by Stanford University. The trial plans to enroll 144 participants.