BridgeMD
New treatment option for Fragile X Syndrome
Official title Metformin in Children With Fragile X Syndrome
ClinicalTrials.gov ID: NCT05120505
What this study is testing
What is Metformin?
Metformin is an investigational medicine, being studied as a potential treatment for fragile x syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 16
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.