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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 13 and 30 years old.
Select...
I am male.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Aberrant Behavior Checklist (ABC)
Digital Biomarkers
EEG
+4 moreSide effects data
From 2013 Phase 2 trial • 20 Patients • NCT0122808435%
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
429 Previous Clinical Trials
64,222 Total Patients Enrolled
9 Trials studying Autism Spectrum Disorder
167 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a seizure in the last 2 years.I am between 13 and 30 years old.I have been taking Avmacol or similar broccoli extracts since my last study.I can attend all study visits and follow the treatment plan.I haven't had a major illness or surgery in the last 3 months.I have a history of chronic kidney, liver, or thyroid disease.My kidney function is impaired with a creatinine level over 1.2 mg/dl.My liver function tests are more than twice the normal limit.My thyroid function is not normal.I am currently fighting an infection or taking antibiotics.I am either younger than 13 or older than 30 years old.I am female.I am male.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What site did they apply to?
Rutgers-RWJMS Department of Neurology
What portion of applicants met pre-screening criteria?
Did not meet criteria
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