drugset / Trial / NCT03479476

A Trial of Metformin in Individuals With Fragile X Syndrome

NCT03479476

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a controlled trial of metformin in individuals with fragile X syndrome between the ages of 6 and 25 years. Participants will be randomized in a double-blind design to either drug or placebo and will attend three visits to the study site in a 4-month period for a series of tests. The primary objectives are to assess safety, tolerability, and efficacy of metformin in the treatment of language deficits, behavior problems, and obesity/excessive appetite in individuals with fragile X syndrome.

Timeline

Start
2018-04-30
Primary completion
2024-05-22
Completion
2024-05-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 1000 mg
Comparator Metformin Small molecule 2000 mg