Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder; Autistic Disorder; Neurodevelopmental Disorder; Childhood Developmental Disorders, Pervasive
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Developmental Disabilities
Intervention: Sulforaphane; Placebo
Intervention description: The investigational medicinal product is an uncoated tablet containing both glucoraphanin and myrosinase, the enzyme that converts glucoraphanin to sulforaphane in vivo. Participants in this arm will take 3-8 tablets by mouth once daily (dose depending upon weight) for 12 weeks.; Placebo tablets are uncoated and matched in appearance to the investigational medicinal product, containing inert components. Participants in this arm will take 3-8 tablets by mouth once daily (dose depending upon weight) for 12 weeks.
Intervention MeSH terms: Sulforaphane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: Male
Minimum age: 13 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: sulforaphane; glucoraphanin; physiologic effects of drugs

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.
    

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