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

Autism Spectrum Disorder Clinical Trial

Official title:

Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: an Open Label Extension

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
• 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
• 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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

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