Metformin in Children With Fragile X Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-16
SponsorChildren's Hospital of Fudan University
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Malnutrition
Primary heart disease
Severe infection or acute clinical illness
Gastrointestinal, renal, or hepatic disease
Trial design
Treatments tested in this trial
- Metformin
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov