Clinical Trial

Metformin in Children With Fragile X Syndrome

Recruiting Phase 4
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Record status
This record was last updated February 18, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-11-03; most recent amendment 2025-02-16.
Status change: Not Yet Recruiting → Recruiting 2022-02-10
Trial Details
NCT Number NCT05120505
Lead Sponsor Children's Hospital of Fudan University
Conditions Fragile X Syndrome, Metformin
Enrollment 20 participants
Start Date 2021-12-29
Primary Completion 2025-12-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-18