Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder (NCT02909959) | Clinical Trial Compass
CompletedPhase 2
Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder
United States48 participantsStarted 2017-03-01
Plain-language summary
The aim of this randomized controlled trial is to determine if a nutritional supplement containing broccoli sprout and seed extracts, a rich source of sulforaphane, is effective in reducing core symptoms of autism spectrum disorder (ASD). The study will also explore the safety and tolerability of a sulforaphane supplement in young men with ASD, as well as its effects on challenging neuropsychiatric symptoms that are commonly associated with ASD, such as hyperactivity, irritability, and repetitive movements.
Who can participate
Age range
13 Years – 30 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males between ages 13-30 (inclusive) at the time of the consent
* Primary diagnosis of Autism Spectrum Disorder (ASD), confirmed by Diagnostic and Statistical Manual-5 (DSM-5) criteria and meeting the autism cut-off score of 9 or greater on the Autism Diagnostic Observation Schedule-2 (ADOS-2)
* Participant is capable of giving written informed consent or has a legally authorized representative (LAR) with sufficient capacity to provide written informed consent on the participant's behalf.
* Participant has a reliable informant (parent or caregiver) who has sufficient past and current knowledge of the subject and will oversee the administration of study medication and accompany the subject to each study visit.
* Participant and caregiver have reliable means of transportation to attend study visits.
Exclusion Criteria:
* Chronic medical illness that is not stable or would pose a risk to the participant if he participates in the trial
* History of clinical seizures within the 12 months preceding study enrollment
* Known genetic disorder that is presumed to be the cause of autism spectrum disorder (eg., Fragile x syndrome, tuberous sclerosis)
* Changes to psychopharmacological medications (e.g., stimulants, antidepressants, anxiolytics, antipsychotics) in the 4 weeks preceding study enrollment
* Significant changes to non-pharmacological treatments for ASD in the 4 weeks preceding study enrollment
* Chronic treatment with anti-inflammatory agents (e.g., i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Social Responsiveness Scale-2 (SRS-2) Total Score at Baseline
Timeframe: Baseline
2
Social Responsiveness Scale-2 (SRS-2) Total Score at Week 4
Timeframe: Week 4
3
Social Responsiveness Scale-2 (SRS-2) Total Score at Week 8
Timeframe: Week 8
4
Social Responsiveness Scale-2 (SRS-2) Total Score at Week 12
Timeframe: Week 12
5
Social Responsiveness Scale-2 (SRS-2) Total Score at Week 16