Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04278898
• Other study ID #: IRB-54931
• Secondary ID: 1K99HD101702
• Status: Recruiting
• Phase: Phase 2
• Start date: February 12, 2021
• Est. completion date: January 2025

Study information

• Verified date: June 2024
• Source: Stanford University
• Contact: John Hegarty, PhD
• Phone: (650) 723-7845
• Email: autismresearch[@]stanford.edu
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: January 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• presence of known genetic abnormalities associated with Autism Spectrum Disorder (e.g. Fragile X),

• current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia),

• presence of significant medical problems that would interfere with participation,

• the inability of at least one caregiver to speak/read English to a sufficient level to complete study requirements and materials,

• individuals taking antioxidant agents and glutathione prodrugs, or

• the inability/unwillingness to swallow an agent during the screening visit.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Drug:
• N-Acetylcysteine
N-acetylcysteine Single Dose 2700 mg taken orally

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)		1 hour after single dose
Secondary	Change in Gamma band amplitude and synchronization measured by electroencephalography		1 hour after single dose