drugset / Trial / NCT01474993

Sulforaphane-rich Broccoli Sprout Extract for Autism

NCT01474993

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2011-12
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Sulforaphane Small molecule 0.05 mmol Oral
Subject Sulforaphane Small molecule 0.1 mmol Oral
Subject Sulforaphane Small molecule 0.15 mmol Oral

Indications