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

This study is currently recruiting participants.
Verified August 2017 by William G. Johnson, M.D, Rutgers, The State University of New Jersey
Sponsor:
ClinicalTrials.gov Identifier:
NCT02677051
First Posted: February 9, 2016
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Rowan University
Information provided by (Responsible Party):
William G. Johnson, M.D, Rutgers, The State University of New Jersey
  Purpose
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.

Condition Intervention Phase
Autism Autistic Disorder Drug: Sulforaphane Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by William G. Johnson, M.D, Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Change in Aberrant Behavior Checklist (ABC) scores. [ Time Frame: 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. ]
  • Clinical Global Impression Severity Scale (CGI-S). [ Time Frame: 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. ]

Secondary Outcome Measures:
  • 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. ]
  • 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. ]
  • 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. ]

Estimated Enrollment: 40
Study Start Date: February 2016
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
About 15 subjects will be randomized into this arm, receiving pills with an inactive placebo.
Drug: 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

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.
Other Name: Avmacol

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677051


Contacts
Contact: Edward S Stenroos 732 235 5490 stenroos@rutgers.edu
Contact: William G Johnson, M.D. 732 235 4508 wjohnson@rutgers.edu

Locations
United States, New Jersey
Rutgers University - Staged Research Building Recruiting
Piscataway, New Jersey, United States, 08854
Contact: Edward S Stenroos    732-235-5490    stenroos@rutgers.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Rowan University
Investigators
Principal Investigator: William G Johnson, M.D. Rutgers-RWJMS
  More Information

Publications:
Responsible Party: William G. Johnson, M.D, Professor of Neurology, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02677051     History of Changes
Other Study ID Numbers: Pro20120001884
CAUT15APL013 ( Other Grant/Funding Number: NJ Governor's Council, Autism )
First Submitted: January 28, 2016
First Posted: February 9, 2016
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents