Efficacy and Safety of Metformin in the Treatment of Fragile X Syndrome
Who is this study for? Patients with fragile x syndrome
What treatments are being studied? Metformin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 16
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Children's Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Qiong Xu, Phd MD
stellaxuqiong@hotmail.com
862164931275
Backup
Chunchun Hu, MD
14211240007@fudan.edu.com
862164931275
Time Frame
Start Date: 2021-12-29
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 20
Treatments
Experimental: Metformin group
The patients will be obtain Metformin starting from 50mg everyday to 1-2g per day for 6 months.
Placebo_comparator: Placebo group
The patients will be obtain starch tablets starting from 50mg everyday to 1-2g per day for 6 months.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Fudan University