Fragile X Syndrome Clinical Trial
Official title:
A Parallel Group Design Randomized Double-Blind Trial of Metformin Treatment in Patients With Fragile X Syndrome on Safety and Effects on Cognition, Anxiety, Attention and Biomarkers
The purpose of this trial is to investigate the use of metformin in the treatment of Fragile X syndrome (FXS) patients. Metformin is an FDA approved compound with an established safety profile and minimal side effects that specifically targets and normalizes multiple aspects of the pathophysiology in FXS. This is a randomized double-blind placebo-controlled 2-arm parallel group design study of the drug metformin and placebo in FXS subjects with a primary outcome measure of safety/tolerability and secondary outcome measures on cognition, attention, anxiety, sleep, and physiologic and biochemical biomarkers.
This trial will be a randomized placebo controlled, double-blind, parallel group design study
of treatment with metformin on the primary outcome of safety/tolerance with secondary outcome
measurements of the effects on cognition (encompassing social and repetitive behavior),
attention, anxiety, and physiological and biochemical biomarkers of patients with FXS. FXS
represents a well-defined population of ASD in which to test a specific targeted treatment
looking at a well-defined set of cognitive and bioassay measures.
Trial length is designed to have a chance at seeing if the medication can improve cognitive
outcome measures. The study duration includes the screening period and a 24-week single-blind
drug/placebo phase.
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