Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT02909959
Eligibility Criteria:
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., ibuprofen, NSAIDs, corticosteroids)
* Clinically significant laboratory abnormalities at Screening visit (e.g., AST/ALT\> two times the upper normal limits; serum creatinine \> 1.2 mg/dl, TSH outside normal limits)
* Clinically significant findings on physical examination that investigator determines could increase risk of harm from participating in the study
* Participated in another clinical interventional trial or received an investigational product in the 30 days preceding study enrollment
* Previous therapeutic trial of sulforaphane or participation in a clinical trial in which sulforaphane was the investigational agent
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
13 Years
Maximum Age:
30 Years
Study:
NCT02909959
Study Brief:
Protocol Section:
NCT02909959