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 — DRUG12 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | - |
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