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

Autism Spectrum Disorder Clinical Trial

Official title:

Sulforaphane in Autism: A Treatment Trial to Confirm Phenotypic Improvement With Sulforaphane Treatment in a New Jersey (NJ) Population of Individuals With Autism

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02677051
• Other study ID #: Pro20120001884
• Secondary ID: CAUT15APL013
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 2016
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a double blind randomized treatment trial that will test if sulforaphane improves core symptoms in autism. It is designed to try to replicate a previous trial (ClinicalTrials.gov Identifier NCT01474993) which reported that the isothiocyanate, sulforaphane treatment led to improvement by multiple metrics. Significant improvement was seen in behavior as measured by the Aberrant Behavioral Checklist (ABC) and by the Social Responsiveness Scale (SRS). In addition a significantly greater number of participants receiving sulforaphane had improvement in social interaction, abnormal behavior, and verbal communication as per the Clinical Global Impression (CGI). In addition The investigators will attempt to account for some variability in response to sulforaphane treatment by testing alleles of genes that are relevant in sulforaphane metabolism. The investigators will also measure glutathione levels, which are also important in sulforaphane metabolism and are in part regulated by sulforaphane.. Sulforaphane is the most potent naturally occurring inducer of mammalian cytoprotective enzymes known. Therapeutic potential is based at least in part on their ability to up-regulate genes responsible for alleviation of oxidative stress and to regulate both the immune system and the inflammatory response 40 Males with autistic disorder will be randomly selected to receive either sulforaphane or placebo. Seven visits are required by the subjects including enrollment ,screening, baseline, weeks 4, 10 and 18 and a follow up visit at seek 22.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 13 Years to 30 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Behavior
• Autistic Disorder

Intervention

Drug:
• Sulforaphane
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.
• Placebo

Locations

Country	Name	City	State
United States	Rutgers University - Staged Research Building	Piscataway	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Rowan University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Aberrant Behavior Checklist (ABC) scores.		Baseline, week 4, week 10, week 18 and week 22.
Primary	Change in Social Responsiveness Scale (SRS) scores.		Baseline, week 4, week 10, week 18 and week 22.
Primary	Clinical Global Impression Severity Scale (CGI-S).		Baseline
Primary	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	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.
Secondary	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.
Secondary	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.