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

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ClinicalTrials.gov Identifier: NCT02677051
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Rowan University
Information provided by (Responsible Party):
William G. Johnson, M.D, Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 9, 2016
Last Update Posted Date October 11, 2019
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02677051 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2016)
  • 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • 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 10, 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 10, 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 10, week 18 and week 22. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sulforaphane in a New Jersey (NJ) Population of Individuals With Autism
Official Title  ICMJE Sulforaphane in Autism: A Treatment Trial to Confirm Phenotypic Improvement With Sulforaphane Treatment in a New Jersey (NJ) Population of Individuals With Autism
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism
  • Autistic Disorder
  • Autism Spectrum Disorder
  • Autistic Behavior
Intervention  ICMJE
  • 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
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    About 15 subjects will be randomized into this arm, receiving pills with an inactive placebo.
    Intervention: 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

    Intervention: Drug: Sulforaphane
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 13 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Edward S Stenroos 732 235 5490 stenroos@rutgers.edu
Contact: William G Johnson, M.D. 732 235 4508 wjohnson@rutgers.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02677051
Other Study ID Numbers  ICMJE Pro20120001884
CAUT15APL013 ( Other Grant/Funding Number: NJ Governor's Council, Autism )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party William G. Johnson, M.D, Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE Rowan University
Investigators  ICMJE
Principal Investigator: William G Johnson, M.D. Rutgers-RWJMS
PRS Account Rutgers, The State University of New Jersey
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP