drugset / Trial / NCT04141163
Metformin in Patients With Fragile X
Phase 1/2
Unknown
40 enrolled
Rowan University
FRAXA Research Foundation · collabUniversity of Pennsylvania · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this trial is to investigate the use of metformin in the treatment of Fragile X syndrome (FXS) patients. Metformin is an FDA approved compound with an established safety profile and minimal side effects that specifically targets and normalizes multiple aspects of the pathophysiology in FXS. This is a randomized double-blind placebo-controlled 2-arm parallel group design study of the drug metformin and placebo in FXS subjects with a primary outcome measure of safety/tolerability and secondary outcome measures on cognition, attention, anxiety, sleep, and physiologic and biochemical biomarkers.
Timeline
- Start
- 2019-10-29
- Primary completion
- 2021-03
- Completion
- 2021-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 1000 mg | Oral |