NCT05664789

Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial

Recruiting now Phase 2, PHASE3 Last updated 20 January 2026

What this trial tests

Phase 2, PHASE3 trial testing N acetyl cysteine in Autism Spectrum Disorder in 144 participants. Currently enrolling.

Timeline

26 April 2023

Primary endpoint
31 January 2028

31 July 2028

Quick facts

Lead sponsor	Stanford University
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	144
Start date	26 April 2023
Primary completion	31 January 2028
Estimated completion	31 July 2028
Sites	1 location across United States

Drugs / interventions tested

• N acetyl cysteine — full drug profile →
• Placebo

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Stanford University

Who can join

Adults 3 to 12, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Novel therapeutics in autism spectrum disorder.
   Sara Daniella Kevelson, Elmaghraby R, Patel F, Brown H, et al · · 2026 · cited 1× · PMID 41748402 · DOI 10.1016/j.neurot.2026.e00857