From FRAXA Foundation:
FRAXA Research Foundation is funding a clinical trial of metformin for teens and adults with Fragile X syndrome. The trial is being conducted by Dr. Sean McBride and colleagues at Rowan University in New Jersey, in collaboration with the University of Pennsylvania. Men and women ages 16-50 with Fragile X syndrome are invited to participate.
A Parallel Group Design, Randomized Double-Blind Controlled Trial of Metformin Treatment in Patients with Fragile X Syndrome, to Evaluate Safety and Effects on Cognition, Anxiety, Attention and Biomarkers.
Clinical Trial Details
In this clinical trial we will enroll 40 male subjects with Fragile X syndrome ages 16-50. The trial is blinded and the subjects will be randomized to either the placebo or the metformin group for the 24 week trial. The primary outcome measure will be to assess safety and side effects. Metformin has a well-established record of safety in non-diabetic individuals. Furthermore, the trial will examine if there are improvements in cognition, sleep, attention and anxiety, as well as examining the effects on markers in blood obtained by standard blood draw. There will be testing performed at weeks 0, 6, 12 and 24 of the trial and additionally clinical contact will be made by phone every two weeks when subjects are not seen in the clinic. This is a collaboration between the Perelman School of Medicine of the University of Pennsylvania and Rowan School of Medicine of Rowan University. We thank our team of collaborators including Dr. Craig Erickson, Dr. Elizabeth Berry-Kravis, Dr. Dejan Budimirovic and Dr. Alex Kolevzon.
Any patients individuals that participate in the study may also continue to see Dr. McBride for follow up treatment beyond the study as they wish.
See more information here
Their entry on clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT04141163
Please contact Sean McBride for any questions about the study!
