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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
Must not have
Impaired renal function (serum creatinine > 1.2 mg/dl)
Current infection or treatment with antibiotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial tests if sulforaphane, a compound from broccoli, can improve symptoms in males with autism. Sulforaphane boosts protective enzymes and helps manage stress and immune responses. The study aims to see improvements in social interaction, behavior, and communication. Sulforaphane, derived from broccoli sprouts, has shown potential benefits in previous trials for improving behavior and social responsiveness in individuals with autism spectrum disorder (ASD).

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.
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.
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
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I am male.
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I am between 13 and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is impaired with a creatinine level over 1.2 mg/dl.
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I am currently fighting an infection or taking antibiotics.
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My liver function is not more than twice the normal limit.
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I am female.
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I haven't had a major illness or surgery in the last 3 months.
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My thyroid function is not normal.
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I am willing and able to follow the study's schedule and treatments.
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I am either younger than 13 or older than 30.
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I have had a seizure in the last 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%
0%
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

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
440 Previous Clinical Trials
65,334 Total Patients Enrolled
9 Trials studying Autism Spectrum Disorder
129 Patients Enrolled for Autism Spectrum Disorder
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 Spectrum Disorder Research Study Groups: Placebo, Sulforaphane
Autism Spectrum Disorder Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT02677051 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT02677051 — Phase 2
~1 spots leftby Dec 2024
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