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RECRUITING
NCT05120505
PHASE4

Metformin in Children With Fragile X Syndrome

Sponsor: Children's Hospital of Fudan University

View on ClinicalTrials.gov

Summary

This study is a controlled trial of metformin in children with fragile X syndrome(FXS). The age of FXS children range from 2 to 16 years old. Participants will be randomized in a double-blind design to either drug or placebo for 6-month period. The primary objectives are to assess metformin in treatment of behavior problems, cognitive and language with fragile X syndrome.

Official title: Efficacy and Safety of Metformin in the Treatment of Fragile X Syndrome

Key Details

Gender

All

Age Range

2 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2021-12-29

Completion Date

2025-12-30

Last Updated

2025-02-18

Healthy Volunteers

No

Interventions

DRUG

Metformin

The patients in this group will be obtain Metformin starting from 50mg everyday at night, and gradually increase to maximum tolerable dose of 1-2g per day according to weights of patients for 6 months.

DRUG

Placebo

The patients in this group will be obtain starch tablets (which had same appearance and size comparing to Metformin) starting from 50mg everyday to 1-2g per day according to weights of patients for 6 months.

Locations (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China