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| ID | Type | Description | Link |
|---|---|---|---|
| CAUT15APL013 | Other Grant/Funding Number | NJ Governor's Council, Autism |
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| Name | Class |
|---|---|
| Rowan University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | About 15 subjects will be randomized into this arm, receiving pills with an inactive placebo. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulforaphane | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Aberrant Behavior Checklist (ABC) scores. | Baseline, week 4, week 10, week 18 and week 22. | |
| Change in Social Responsiveness Scale (SRS) scores. | Baseline, week 4, week 10, week 18 and week 22. | |
| Clinical Global Impression Severity Scale (CGI-S). | Baseline | |
| Clinical Global Impression Improvement Scale (CGI-I) to measure change from baseline CGI-S scores. | Week 4, week 10, week 18 and week 22. |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Function Tests as a screen for entry into the study and a monitor of potential change/adverse events due to treatment. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Buyske | Rutgers, The State University of NJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers University - Staged Research Building | Piscataway | New Jersey | 08854 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25313065 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2023 | Sep 2, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 28, 2021 | Sep 2, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C016766 | sulforaphane |
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| Placebo | Drug |
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| 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. | Baseline, week 4, week 18 and week 22. |