Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Autism Spectrum Disorder, Autistic Disorder, Neurodevelopmental Disorder, Childhood Developmental Disorders, Pervasive

In brief

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.

Key facts

Study ID

NCT02909959

Run by

University of North Carolina, Chapel Hill

People needed

48

Starts

2017-03-01

Expected to finish

2019-05-30

Last updated by the study team

2020-06-04

Who can join

Age: 13 and older, up to 30. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Carolina Institute for Developmental Disabilities, University of North Carolina School of Medicine — Carrboro, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.