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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT05494398
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
3 Years - 13 Years
Healthy Volunteers
Not accepted

Interventions

  • N-acetylcysteine — DRUG
    12 week administration of N-Acetylcysteine to target restricted repetitive behavior severity.

Study Details

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.

Key Dates

Start date
Mar 12, 2024
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
144 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: N-Acetylcysteine

Primary Outcome Measure

Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline and Week 12 of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-

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