Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder

• Status: Completed
• Trial end date: 2019-05-30
• Target enrollment: 0
• Participant gender: Male

Summary

The aim of this randomized controlled trial is to determine if a nutritional supplement containing broccoli sprout and seed extracts, a rich source of sulforaphane, is effective in reducing core symptoms of autism spectrum disorder (ASD). The study will also explore the safety and tolerability of a sulforaphane supplement in young men with ASD, as well as its effects on challenging neuropsychiatric symptoms that are commonly associated with ASD, such as hyperactivity, irritability, and repetitive movements.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: North Carolina Translational and Clinical Sciences Institute
• Treatments: Sulforafan; Sulforaphane

Criteria

Inclusion Criteria:

• Males between ages 13-30 (inclusive) at the time of the consent

• Primary diagnosis of Autism Spectrum Disorder (ASD), confirmed by Diagnostic and Statistical Manual-5 (DSM-5) criteria and meeting the autism cut-off score of 9 or greater on the Autism Diagnostic Observation Schedule-2 (ADOS-2)

• Participant is capable of giving written informed consent or has a legally authorized representative (LAR) with sufficient capacity to provide written informed consent on the participant's behalf.

• Participant has a reliable informant (parent or caregiver) who has sufficient past and current knowledge of the subject and will oversee the administration of study medication and accompany the subject to each study visit.

• Participant and caregiver have reliable means of transportation to attend study visits.

Exclusion Criteria:

• Chronic medical illness that is not stable or would pose a risk to the participant if he participates in the trial

• History of clinical seizures within the 12 months preceding study enrollment

• Known genetic disorder that is presumed to be the cause of autism spectrum disorder (eg., Fragile x syndrome, tuberous sclerosis)

• Changes to psychopharmacological medications (e.g., stimulants, antidepressants, anxiolytics, antipsychotics) in the 4 weeks preceding study enrollment

• Significant changes to non-pharmacological treatments for ASD in the 4 weeks preceding study enrollment

• Chronic treatment with anti-inflammatory agents (e.g., ibuprofen, NSAIDs, corticosteroids)

• Clinically significant laboratory abnormalities at Screening visit (e.g., AST/ALT> two times the upper normal limits; serum creatinine > 1.2 mg/dl, TSH outside normal limits)

• Clinically significant findings on physical examination that investigator determines could increase risk of harm from participating in the study

• Participated in another clinical interventional trial or received an investigational product in the 30 days preceding study enrollment

• Previous therapeutic trial of sulforaphane or participation in a clinical trial in which sulforaphane was the investigational agent