Actively Recruiting

Phase 4
Age: 2Years - 16Years
All Genders
NCT05120505

Metformin in Children With Fragile X Syndrome

Led by Children's Hospital of Fudan University · Updated on 2025-02-18

20

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Metformin in Children With Fragile X Syndrome

Who Can Participate

Age: 2Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Genetic testing confirms the diagnosis of FXS
  • Participation secured with informed consent from guardian
  • Body mass index (BMI) above the 3rd percentile
  • Taking no more than two therapeutic drugs
  • Able to attend regular follow-up visits
Not Eligible

You will not qualify if you...

  • Malnutrition
  • Primary heart disease
  • Severe infection or acute clinical illness
  • Gastrointestinal, renal, or hepatic disease
  • Previous history of lactic acidosis
  • Previous intolerance to metformin
  • Use of angiotensin converting enzyme inhibitors, anticoagulants, or presence of vitamin B12 deficiency
  • Alcohol consumption
  • Unstable systemic diseases other than FXS
  • Recent changes in clinical medication

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 201102

Actively Recruiting

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Research Team

Q

Qiong Xu, Phd MD

CONTACT

C

Chunchun Hu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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