AutismPhase 2NCT02677051
Sulforaphane in a New Jersey (NJ) Population of Individuals With Autism
A Phase 2 study testing Sulforaphane in people with Autism and Autistic Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 30 years, men only
- Conditions the study is for
- Autism, Autistic Disorder, Autism Spectrum Disorder
- What is being tested?
- Sulforaphane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 30 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Autistic disorder diagnosis.
- Age between 13-30 years.
- Male gender.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers University - Staged Research Building
Piscataway, New Jersey, 08854
About this study
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
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.
Read the 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.
- Conditions
- Autism, Autistic Disorder, Autism Spectrum Disorder, Autistic Behavior
- Being tested
- Sulforaphane, Placebo
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulforaphaneDrug
Also called Avmacol
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.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | About 15 subjects will be randomized into this arm, receiving pills with an inactive placebo. Receives: Drug: Placebo |
| Sulforaphane | Experimental | 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 Receives: Drug: Sulforaphane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aberrant Behavior Checklist (ABC) scores.
Measured: Baseline, week 4, week 10, week 18 and week 22.
Change in Social Responsiveness Scale (SRS) scores.
Measured: Baseline, week 4, week 10, week 18 and week 22.
Clinical Global Impression Severity Scale (CGI-S).
Measured: Baseline
Clinical Global Impression Improvement Scale (CGI-I) to measure change from baseline CGI-S scores.
Measured: Week 4, week 10, week 18 and week 22.
Secondary outcomes (3)
Liver Function Tests as a screen for entry into the study and a monitor of potential change/adverse events due to treatment.
Measured: 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.
Measured: 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.
Measured: Baseline, week 4, week 18 and week 22.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Rowan University
- Responsible party
- Principal investigator, Steven Buyske, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Steven Buyske, Principal investigator, Rutgers, The State University of NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677051
- Sponsor's protocol ID
- Pro20120001884
- Other IDs
- CAUT15APL013
- Status last verified
- Oct 2025
- First submitted
- 28 Jan 2016
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25313065
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02677051
- Acronym / sponsor ID
- Pro20120001884
- Conditions
- Autism, Autistic Disorder, Autism Spectrum Disorder, Autistic Behavior
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Rowan University
- Study start
- Feb 2016
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboAbout 15 subjects will be randomized into this arm, receiving pills with an inactive placebo. |
| Sulforaphane | Experimental | Drug: SulforaphaneAbout 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 |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Autistic disorder diagnosis.
- Age between 13-30 years.
- Male gender.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SulforaphaneAlso: AvmacolSulforaphane (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. | Drug | Sulforaphane |
| Placebo | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Background: PubMed 25313065Singh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Buyske principal investigator
Rutgers, The State University of NJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulforaphane in people with Autism and Autistic Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aberrant Behavior Checklist (ABC) scores. (time frame: Baseline, week 4, week 10, week 18 and week 22.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02677051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.