Sulforaphane in a New Jersey (NJ) Population of Individuals With Autism
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02677051|
Recruitment Status : Active, not recruiting
First Posted : February 9, 2016
Last Update Posted : November 16, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Autism Autistic Disorder Autism Spectrum Disorder Autistic Behavior||Drug: Sulforaphane Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||July 2023|
Placebo Comparator: Placebo
About 15 subjects will be randomized into this arm, receiving pills with an inactive placebo.
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 Name: Avmacol
- 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. ]
- 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. ]
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|
- Autistic disorder diagnosis.
- Age between 13-30 years.
- Male gender.
- 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.
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
|United States, New Jersey|
|Rutgers University - Staged Research Building|
|Piscataway, New Jersey, United States, 08854|
|Principal Investigator:||Steven Buyske||Rutgers, The State University of NJ|
Documents provided by Steven Buyske, Ph.D., Rutgers, The State University of New Jersey:
|Responsible Party:||Steven Buyske, Ph.D., Associate Professor, Rutgers, The State University of New Jersey|
|Other Study ID Numbers:||
CAUT15APL013 ( Other Grant/Funding Number: NJ Governor's Council, Autism )
|First Posted:||February 9, 2016 Key Record Dates|
|Last Update Posted:||November 16, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Physiological Effects of Drugs