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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Metformin
DrugThe 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
DrugThe 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Metformin groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change of scores of Aberrant Behavior Checklist (ABC)
Difference on the scores of the ABC from baseline to the 6th month. ABC is a 58-item behavior scale ranked from 0("not a problem") to 3("severe problem") being the most severe for each item. 5 subscales include irritability, lethargy, stereotypy , hyperactivity and inappropriate speech. The same parent of patient will complete the checklist from baseline to 6th month. The global score changes of ABC will be measured as the primary outcome.
Time frame
From baseline to the 6th monthSponsors and contacts
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Source ClinicalTrials.gov