Metformin in Children With Fragile X Syndrome
Recruiting
Phase 4
Interventional Study
Fragile X Syndrome
Metformin
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 – 16
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Children's Hospital of Fudan University · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Malnutrition
* Primary hea…
Contacts