Sulforaphane for Autism

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Autism+4 MoreSulforaphane - Drug
Eligibility
13 - 30
Male
What conditions do you have?
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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

1 of 3

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

2 of 3
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
This histogram enumerates side effects from a completed 2013 Phase 2 trial (NCT01228084) in the Sulpforaphane ARM group. Side effects include: Flatulence with 35%, Nausea with 35%, Diarrhea with 20%, Bloating with 20%, Dyspepsia with 20%.

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: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
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?
Missouri100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Rutgers University - Staged Research Building100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%