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

August 18, 2023 updated by: Steven Buyske, Ph.D., Rutgers, The State University of New Jersey

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

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Rutgers University - Staged Research Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
About 15 subjects will be randomized into this arm, receiving pills with an inactive placebo.
Experimental: Sulforaphane

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

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.
Other Names:
  • Avmacol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Aberrant Behavior Checklist (ABC) scores.
Time Frame: Baseline, week 4, week 10, week 18 and week 22.
Baseline, week 4, week 10, week 18 and week 22.
Change in Social Responsiveness Scale (SRS) scores.
Time Frame: Baseline, week 4, week 10, week 18 and week 22.
Baseline, week 4, week 10, week 18 and week 22.
Clinical Global Impression Severity Scale (CGI-S).
Time Frame: Baseline
Baseline
Clinical Global Impression Improvement Scale (CGI-I) to measure change from baseline CGI-S scores.
Time Frame: Week 4, week 10, week 18 and week 22.
Week 4, week 10, week 18 and week 22.

Secondary Outcome Measures

Outcome Measure
Time Frame
Liver Function Tests as a screen for entry into the study and a monitor of potential change/adverse events due to treatment.
Time Frame: Baseline, week 4, week 18 and week 22.
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.
Time Frame: Baseline, week 4, week 18 and week 22.
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.
Time Frame: Baseline, week 4, week 18 and week 22.
Baseline, week 4, week 18 and week 22.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Steven Buyske, Rutgers, The State University of NJ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimated)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Pro20120001884
  • CAUT15APL013 (Other Grant/Funding Number: NJ Governor's Council, Autism)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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