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

Stanford University

Status and phase: Invitation-only; Phase 3; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05494398

K99HD101702 (U.S. NIH Grant/Contract)

IRB-64292

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 3 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• participation in an associated single-dose (IRB-54931, NCT04278898) or randomized, controlled trial of NAC (IRB-63262, NCT05664789).
• stable medication regimens (≥ 30 days) with no anticipated changes during the trial.

Exclusion criteria

• the presence of significant medical problems that reduce medical stability.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

N-Acetylcysteine

Experimental group

Treatment:

Drug: N-acetylcysteine