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Phytochemical

Sulforaphane for Autism Spectrum Disorder

N/A
Waitlist Available
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
Age between 13-30 years
Male gender
Must not have
Those that started or continued taking Avmacol® or similar broccoli extracts since leaving our double-blind study
Those that can not or will not complete all visits and adherence to study regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16.
Awards & highlights

Summary

This trial uses digital biomarkers to track changes from a compound found in vegetables in order to better understand how it affects autism.

Who is the study for?
This trial is for males aged 13-30 with a diagnosis of autistic disorder who previously participated in clinical trial NCT02677051. It's not for those using broccoli extracts post-trial, without guardian consent, unable to commit to the study schedule, or with recent seizures, kidney/liver/thyroid disease, infections, antibiotics use, or major surgery within 3 months.
What is being tested?
The study tests if sulforaphane treatment effects on Autism Spectrum Disorder can be tracked using digital biomarkers like heart rate and muscle movement. These are measured non-invasively and aim to enhance traditional clinical scores used in autism research.
What are the potential side effects?
While specific side effects of sulforaphane aren't detailed here, it's generally considered safe when consumed through diet. In supplement form at high doses or long-term use could potentially cause stomach upset or other gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 13 and 30 years old.
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I am male.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been taking Avmacol or similar broccoli extracts since my last study.
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I can attend all study visits and follow the treatment plan.
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I have a history of chronic kidney, liver, or thyroid disease.
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My kidney function is impaired with a creatinine level over 1.2 mg/dl.
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My liver function tests are more than twice the normal limit.
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My thyroid function is not normal.
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I am currently fighting an infection or taking antibiotics.
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I am either younger than 13 or older than 30 years old.
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I am female.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16.
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Aberrant Behavior Checklist (ABC)
Digital Biomarkers
EEG
+4 more

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

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
All subjects will receive 1.47umol/kg/day sulforaphane for 12 weeks. Pills are taken once a say with a meal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sulforaphane
2016
Completed Phase 3
~550

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
440 Previous Clinical Trials
65,372 Total Patients Enrolled
9 Trials studying Autism Spectrum Disorder
167 Patients Enrolled for Autism Spectrum Disorder

Media Library

Sulforaphane (Phytochemical) Clinical Trial Eligibility Overview. Trial Name: NCT04805957 — N/A
Autism Spectrum Disorder Research Study Groups: Treatment
Autism Spectrum Disorder Clinical Trial 2023: Sulforaphane Highlights & Side Effects. Trial Name: NCT04805957 — N/A
Sulforaphane (Phytochemical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04805957 — N/A
~1 spots leftby Dec 2024
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