Study Summary
This study is evaluating whether sulforaphane may improve core symptoms in autism.
Eligible Conditions
- Autism
- Autism Spectrum Disorder (ASD)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 3 Secondary · Reporting Duration: Week 4, week 10, week 18 and week 22.
Baseline
Clinical Global Impression Severity Scale (CGI-S).
Week 22
Change in Aberrant Behavior Checklist (ABC) scores.
Change in Social Responsiveness Scale (SRS) scores.
Week 22
Liver Function Tests as a screen for entry into the study and a monitor of potential change/adverse events due to treatment.
Therapeutic procedure
Thyroid Stimulating Hormone (TSH) as a screen for entry into the study and a monitor of potential change/adverse events due to treatment.
Week 22
Clinical Global Impression Improvement Scale (CGI-I) to measure change from baseline CGI-S scores.
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Sulpforaphane
35%Flatulence
35%Nausea
20%Diarrhea
20%Bloating
20%Dyspepsia
15%Gatrointestinal pain
Trial Design
2 Treatment Groups
Sulforaphane
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
48 Total Participants · 2 Treatment Groups
Primary Treatment: Sulforaphane · Has Placebo Group · Phase 2
Sulforaphane
Drug
Experimental Group · 1 Intervention: Sulforaphane · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sulforaphane
Not yet FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 4, week 10, week 18 and week 22.
Who is running the clinical trial?
Rowan UniversityOTHER
21 Previous Clinical Trials
2,705 Total Patients Enrolled
Rutgers, The State University of New JerseyLead Sponsor
376 Previous Clinical Trials
58,580 Total Patients Enrolled
Steven BuyskePrincipal Investigator - Rutgers, The State University of NJ
Rutgers, The State University of New Jersey
Eligibility Criteria
Age 13 - 30 · Male Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:People aged between 13 and 30 years old.
Who else is applying?
What state do they live in?
| Missouri | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Rutgers University - Staged Research Building | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
References
- Singh, Kanwaljit, Susan L. Connors, Eric A. Macklin, Kirby D. Smith, Jed W. Fahey, Paul Talalay, and Andrew W. Zimmerman. 2014. “Sulforaphane Treatment of Autism Spectrum Disorder (ASD)”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1416940111.
- Steven Buyske, Ph.D. 2016. "Sulforaphane in a New Jersey (NJ) Population of Individuals With Autism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02677051.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments