drugset / Trial / NCT01970345

A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder

NCT01970345

RandomizedCrossoverQuadruple-blindTreatment

Summary

The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of autism. We will use a double-blind, placebo-controlled crossover trial design in five children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments in socialization, language, and repetitive behaviors. We expect to provide evidence for the safety and feasibility of IGF-1 in ameliorating social withdrawal in children with Autistic Disorder. Further, we expect to demonstrate that IGF-1 is associated with improvement on secondary outcomes of social impairment, language delay, and repetitive behavior, as well as on functional outcomes of global severity.

Timeline

Start
2014-05
Primary completion
2017-09-13
Completion
2017-09-13

Drugs

EvaluationDrugModalityDoseRoute
Subject mecasermin Protein / enzyme biologic 0.12 mg/kg Subcutaneous