NCT05120505 Metformin in Children With Fragile X Syndrome
| NCT ID | NCT05120505 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Fragile X Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-12-29 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2021-12-29 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 heart disease * Severe infection or acute clinical illness * Gastrointestinal, renal, or hepatic disease * Previous history of lactic acidosis * previous use of metformin intolerant * Use of angiotensin converting enzyme inhibitors, use of anticoagulants, vitamin B12 deficiency, alcohol consumption * Unstable systemic diseases other than FXS * Changes in clinical medication
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05120505 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 16 Years, studying Fragile X Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05120505 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05120505 currently recruiting?
Yes, NCT05120505 is actively recruiting participants. Contact the research team at stellaxuqiong@hotmail.com for enrollment information.
Where is the NCT05120505 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05120505 clinical trial?
NCT05120505 is sponsored by Children's Hospital of Fudan University. The trial plans to enroll 20 participants.