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Metformin in Children With Fragile X Syndrome
Sponsor: Children's Hospital of Fudan University
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
Conditions
Interventions
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.
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