Metformin in Children With Fragile X Syndrome

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Fragile X Syndrome, Metformin

In brief

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.

Key facts

Study ID

NCT05120505

Run by

Children's Hospital of Fudan University

People needed

20

Starts

2021-12-29

Expected to finish

2025-12-30

Last updated by the study team

2025-02-18

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Genetic testing confirms the diagnosis of FXS
• Participate in the study with the informed consent of the guardian
• BMI>the 3rd percentile
• Not taking more than 2 therapeutic drugs
• Able to receive regular follow-up visits

You may not qualify if…

• Malnutrition
• Primary heart disease
• Severe infection or acute clinical illness
• Gastrointestinal, renal, or hepatic disease
• Previous history of lactic acidosis
• previous use of metformin intolerant
• Use of angiotensin converting enzyme inhibitors, use of anticoagulants, vitamin B12 deficiency, alcohol consumption
• Unstable systemic diseases other than FXS
• Changes in clinical medication

Where it is running

• Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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