Clinical Trial Details
Braintumor Website

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NCT01970345 : A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder
PhasePhase 2
AgesMin: 5 Years Max: 12 Years
Inclusion Criteria:

- Meet DSM-5 criteria for Autism Spectrum Disorder confirmed by the Autism Diagnostic
Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule- Generic

- Children between the ages of 5-12 years of age

- Have an Aberrant Behavior Checklist (ABC-SW) score of at least 12

- Language delay (lack of fluent phrase speech) reflected by use of ADOS Module 1 or 2

- Must be on stable medication regimens for at least three months prior to enrollment,
assuming the concomitant medication is safe for use with IGF-1

Exclusion Criteria:

- Closed epiphyses

- Active or suspected neoplasia

- Intracranial hypertension

- Hepatic insufficiency

- Renal insufficiency

- Cardiomegaly/valvulopathy

- History of allergy to IGF-1

- Patients with comorbid conditions deemed too medically compromised to tolerate the
risk of experimental treatment with IGF-1
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