drugset / Trial / NCT04141163

Metformin in Patients With Fragile X

NCT04141163

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2019-10-29
Primary completion
2021-03
Completion
2021-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 1000 mg Oral

Indications