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Sulforaphane for Autism

Phase 2

Waitlist Available

Led By Steven Buyske

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male gender

Age between 13-30 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4, week 10, week 18 and week 22.

Awards & highlights

Study Summary

This trialtests if eating certain veggies (broccoli) can improve autism symptoms. Researchers measure specific chemicals and genes to understand response.

Who is the study for?

This trial is for males aged 13-30 with a diagnosis of autistic disorder in New Jersey. Participants must have a parent or guardian's consent and be able to complete all study visits. They should not have kidney, liver, thyroid issues, current infections, recent major surgery or chronic diseases like heart disease or diabetes.Check my eligibility

What is being tested?

The trial is testing whether sulforaphane can improve core symptoms of autism. Sulforaphane is derived from vegetables like broccoli and will be given in controlled amounts compared to a placebo in a double-blind setup where neither the participants nor the researchers know who receives what treatment.See study design

What are the potential side effects?

While specific side effects are not listed here, sulforaphane generally may cause gas or bowel irritation due to its source being vegetables like broccoli. Any additional side effects would be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am male.

Select...

I am between 13 and 30 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Aberrant Behavior Checklist (ABC) scores.

Change in Social Responsiveness Scale (SRS) scores.

Clinical Global Impression Improvement Scale (CGI-I) to measure change from baseline CGI-S scores.

+1 more

Secondary outcome measures

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.

Side effects data

From 2013 Phase 2 trial • 20 Patients • NCT01228084

35%

Flatulence

35%

Nausea

20%

Bloating

20%

Diarrhea

20%

Dyspepsia

15%

Gatrointestinal pain

100%

80%

60%

40%

20%

Study treatment Arm

Sulpforaphane

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SulforaphaneExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

About 15 subjects will be randomized into this arm, receiving pills with an inactive placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sulforaphane

Not yet FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,184 Total Patients Enrolled

Rowan UniversityOTHER

23 Previous Clinical Trials

2,817 Total Patients Enrolled

Steven BuyskePrincipal Investigator - Rutgers, The State University of NJ

Rutgers, The State University of New Jersey

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT02677051 — Phase 2

Autism Research Study Groups: Placebo, Sulforaphane

Autism Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT02677051 — Phase 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT02677051 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots in this clinical experiment for participants?

"This research is currently paused and no longer accepting participants. It was originally posted on February 1st 2016, with the last edit taking place on November 14th 2022. For those looking for other similar trials, 1137 studies are enrolling patients diagnosed with autistic disorder while 5 clinicals investigate Sulforaphane's efficacy."

Answered by AI

Do applicants over the age of 25 qualify for this clinical endeavor?

"Upon review of the participation requirements, the minimum age for enrolment is 13 years old and no one over 30 can join this clinical trial."

Answered by AI

Is Sulforaphane a safe treatment option for those suffering from medical conditions?

"Sulforaphane has some evidence of safety, which is why we rate it a 2 on the scale. As this is merely a Phase 2 trial, there are no data points that support its efficacy."

Answered by AI

What is the current participant count in this medical trial?

"At present, this clinical trial is no longer accepting new candidates. Initially posted on February 1st 2016 and last updated on November 14th 2022, there are 1137 trials for autistic disorder currently in progress as well as 5 studies involving Sulforaphane that are still recruiting participants."

Answered by AI

What qualifications must be met to partake in this research?

"This research requires 48 participants with autistic disorder who are situated between the ages of 13 and 30 to participate. The primary requirement is that they must fall within this age range."

Answered by AI