Metformin in Patients With Fragile X

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Rowan University
Updated on 12 April 2021
diabetes
anxiety
stimulant
metformin
seizure
antidepressants
antipsychotics
mood stabilizers

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.

Description

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.

Details
Condition Fragile X Syndrome
Treatment Metformin, Placebo Oral Tablet
Clinical Study IdentifierNCT04141163
SponsorRowan University
Last Modified on12 April 2021

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