Sulforaphane in a New Jersey (NJ) Population of Individuals With Autism

NCT02677051 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: Pro20120001884CAUT15APL013
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a double blind treatment trial that will test if sulforaphane improves core symptoms in autism. The investigators expect to see clinical improvement in some of these areas. Sulforaphanes come from eating certain vegetables such as broccoli. The investigators will be using a preparation that gives specific and reproducible amounts. The investigators will also test specific chemicals and genes needed for sulforaphane usage to try to understand differences in response.

Conditions

Autism; Autistic Disorder; Autism Spectrum Disorder; Autistic Behavior

Outcome Measures

Primary Outcomes (4)

• Change in Aberrant Behavior Checklist (ABC) scores.

  Baseline, week 4, week 10, week 18 and week 22.

• Change in Social Responsiveness Scale (SRS) scores.

  Baseline, week 4, week 10, week 18 and week 22.

• Clinical Global Impression Severity Scale (CGI-S).

  Baseline

• Clinical Global Impression Improvement Scale (CGI-I) to measure change from baseline CGI-S scores.

  Week 4, week 10, week 18 and week 22.

Secondary Outcomes (3)

• Liver Function Tests as a screen for entry into the study and a monitor of potential change/adverse events due to treatment.

  Baseline, week 4, week 18 and week 22.

• Renal Function Tests as a screen for entry into the study and a monitor of potential change/adverse events due to treatment.

  Baseline, week 4, week 18 and week 22.

• Thyroid Stimulating Hormone (TSH) as a screen for entry into the study and a monitor of potential change/adverse events due to treatment.

  Baseline, week 4, week 18 and week 22.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

About 15 subjects will be randomized into this arm, receiving pills with an inactive placebo.

Drug: Placebo

Sulforaphane

EXPERIMENTAL

About 30 subjects will be randomized into this arm, receiving pills with glucoraphanin rich broccoli seed powder containing active myrosinase resulting in sulforaphane once ingested Doses will be weight dependent with each pill resulting in \~ 50 µmol sulforaphane. Body weight Dose of sulforaphane 34 kg \~ 50 µmol 68 kg \~ 100 µmol 102 kg \~ 150 µmol

Drug: Sulforaphane

Interventions

Sulforaphane DRUG

Sulforaphane (1-isothiocyanato-4R- (methylsulfinyl)butane) is an isothiocyanate derived from the action of the plant enzyme myrosinase on glucosinolates including glucoraphanin and comes from consumption of many cruciferous vegetables.

Also known as: Avmacol

Sulforaphane

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Autistic disorder diagnosis.
• Age between 13-30 years.
• Male gender.

You may not qualify if:

• Absence of a parent or legal guardian and consent,
• Those that can not or will not complete all visits and adherence to study regimen.
• Seizure within 2 years of screening,
• Impaired renal function (serum creatinine\> 1.2 mg/dl).
• Impaired hepatic function (\> 2x upper limit of normal).
• Impaired thyroid function (TSH outside normal limits).
• Current infection or treatment with antibiotics.
• Chronic medical disorder (e.g., cardiovascular disease, stroke or diabetes) or major surgery within 3 months prior to enrollment.
• Less than 13 years or more than 30 years of age.
• Female gender.
• A diagnosis of autism spectrum disorder other than autistic disorder, for example, Asperger, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) etc.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Rowan University: collaborator

Study Sites (1)

Rutgers University - Staged Research Building

Piscataway, New Jersey, 08854, United States

Location

Related Publications (1)

• Singh K, Connors SL, Macklin EA, Smith KD, Fahey JW, Talalay P, Zimmerman AW. Sulforaphane treatment of autism spectrum disorder (ASD). Proc Natl Acad Sci U S A. 2014 Oct 28;111(43):15550-5. doi: 10.1073/pnas.1416940111. Epub 2014 Oct 13.

  PMID: 25313065 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Steven Buyske

  Rutgers, The State University of NJ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 9, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)