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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05494398
Other study ID # IRB-64292
Secondary ID K99HD101702
Status Enrolling by invitation
Phase Phase 2/Phase 3
First received
Last updated
Start date November 15, 2022
Est. completion date September 2028

Study information

Verified date June 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 48
Est. completion date September 2028
Est. primary completion date September 2027
Accepts healthy volunteers No
Gender All
Age group 3 Years to 13 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
N-acetylcysteine
12 week administration of N-Acetylcysteine to target restricted repetitive behavior severity.

Locations

Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI) Baseline and Week 12 of treatment
Primary Change in restricted and repetitive behaviors as measured by Children's Yale Brown Obsessive Compulsive Scale - Autism Spectrum Disorder (CYBOCS-ASD) Higher scores on the Children's Yale Brown Obsessive Compulsive Scale - Autism Spectrum Disorder mean higher levels of restricted and repetitive behaviors (Raw Score Total Range: 0-20) Screening, Week 8, week 12
Secondary Change in Gamma band amplitude and synchronization measured by electroencephalography (EEG) Baseline, Week 12
Secondary Change in restricted repetitive behavior subtypes as measured by the Restricted Behavior Scale - Revised (RBS-R) Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129) Baseline, week 8, week 12
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