At a glance
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Pharmacological Treatment of Rett Syndrome by Stimulation of Synaptic Maturation With Recombinant Human IGF-1(Mecasermin [rDNA] Injection)
In Brief
A Phase 2 clinical trial evaluating Recombinant Human Insulin Growth Factor 1 (rhIGF-1) and Placebo for Rett Syndrome. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Investigators are recruiting children for a clinical trial using the medication recombinant human IGF-1 (a.k.a. mecasermin or INCRELEX) to see if it improves the health of children with Rett syndrome (RTT). While IGF-1 is approved by the Food \& Drug Administration (FDA) for certain use in children, it is considered an investigational drug in this trial because it has not previously been used to treat RTT. Information from this study will help determine if IGF-1 effectively treats RTT but will not necessarily lead to FDA approval of IGF-1 as a treatment for RTT.
Study Details
Timeline
Interventions
Subjects will receive twice daily subcutaneous injections of IGF-1.
Subjects will receive twice daily subcutaneous injections of a saline solution (placebo).