A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: May 01, 2014
End Date: January 01, 2020
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 (ADOS-G)
- Children between the ages of 5-12 years of age
- 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