At a glance
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Sulforaphane-rich Broccoli Sprout Extract for Autism
In Brief
A Phase 2 clinical trial evaluating Sulforaphane-rich Broccoli Sprout Extract and Placebo for Autism. Completed, enrolled 44 participants across 1 site.
Detailed Summary
The primary objectives of this study are to answer whether there is evidence of measurable effects on social responsiveness (primary outcome) and other behavioral symptoms after treatment of autistic male adolescents and adults with orally administered sulforaphane-rich Broccoli Sprout Extract (efficacy). The secondary objectives of this study are to answer whether treatment of male adolescents and adults with autism using orally administered sulforaphane-rich Broccoli Sprout Extract within a specified dose range is safe (toxicity); treatment with sulforaphane-rich Broccoli Sprout Extract is well tolerated (side effects and adverse events); key cellular biomarkers support the hypothesized mechanisms (proof of principle).
Study Details
Timeline
Interventions
30 subjects will be randomly selected to receive sulforaphane-rich Broccoli Sprout Extract. The medication will be supplied and dispensed as No.1 size gelcaps (each gelcap containing \~ 250 mg sulforaphane rich Broccoli Sprout Extract, equivalent to \~ 50 µmol of sulforaphane). The dosage of sulforaphane will depend on subject's body weight: 1. Subjects with body weight less than 101 lbs will receive \~ 50 micromol sulforaphane per day (1 gelcap to be taken once a day) 2. Subjects with body weight 101 lbs to 199 lbs will receive \~ 100 micromol sulforaphane per day (2 gelcaps to be taken once a day) 3. Subjects with bidy weight \> 199 lbs will receive \~ 150 micromol sulforaphane per day (3 gelcaps to be taken once a day)
15 subjects will be randomly selected to receive inactive placebo (Gelcaps identical in appearance to that of active medication and containing microcrystalline cellulose)