Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: a Single-dose Challenge Study

Who is this study for? Child patients with Autism Spectrum Disorder
What treatments are being studied? N-Acetylcysteine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 12
Healthy Volunteers: f
View:

• children between 3 years and 12 years 11 months at the time of consent

• diagnosis of Autism Spectrum Disorder confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2), or Brief Observation of Symptoms of Autism (BOSA), or Childhood Autism Rating Scale- Second Edition (CARS-2).

• at least moderate Restricted and Repetitive Behaviors severity defined by a Children's Yale-Brown Obsessive Compulsive Scale for children with autism spectrum disorder score ≥ 11,

• physical development indicative of prepubescence as defined by the criteria for Tanner Stage 1,

• medically stable,

• passes MR safety screening (e.g., no metal in the body).

Locations
United States
California
Stanford University School of Medicine
RECRUITING
Stanford
Contact Information
Primary
Brianna Alconcher
autismresearch@stanford.edu
(650) 723-7845
Backup
John Hegarty, PhD
hegartyj@stanford.edu
(650) 723-7845
Time Frame
Start Date: 2021-02-12
Estimated Completion Date: 2027-01
Participants
Target number of participants: 24
Treatments
Experimental: N-acetylcysteine then Placebo
Experimental: Placebo then N-acetylcysteine
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov