NCT01970345.

Study name	A pilot treatment study of insulin‐like growth factor‐1 (IGF‐1) in autism spectrum disorder
Methods	12‐week cross‐over trial of insulin‐like growth factor‐1 (IGF‐1) versus placebo
Participants	Inclusion criteria: children aged 5‐12 years meet the DSM‐5 criteria for ASD language delay "(lack of fluent phrase speech) reflected by use of ADOS Module 1 or 2" must be on stable medication in the 3 months prior to the trial Exclusion criteria: intolerance or allergy to IGF‐1 hepatic or renal insufficiency, intracranial hypertension, cardiomegaly/valvulopathy, or significant medical conditions deemed by the investigators to affect the safe administration of IGF‐1 Setting/location: unknown, although assumed to be in the USA Number of participants: target is 10
Interventions	Intervention (insulin‐like growth factor‐1 (IGF‐1)) for 12 weeks: initiated at 0.04 mg/kg twice daily by injection, increasing to maximum of 0.12 mg/kg twice daily Comparator (placebo) for 12 weeks: equivalent placebo
Outcomes	Primary outcomes: BoC (measured using the Repetitive Behaviour Scale (Bodfish 2000) (subscales unknown)) Secondary outcomes: unclear Timing of outcome assessments: unclear
Starting date	First registered in 2013 and expected to be completed in 2022
Contact information	Name: Bonnie Lerman E‐mail: bonnie.lerman@mssm.edu
Notes	Source of funding: Icahn School of Medicine at Mount Sinai, Autism Science Foundation Conflicts of interest: unclear