drugset / Trial / NCT07209462
Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is a multicenter, double-blind, randomized, placebo-controlled study to assess the safety and tolerability of 3 doses of MRM-3379 in male participants with Fragile X Syndrome ages 16 to 45 (inclusive). In addition, a parallel cohort of participants ages 13 to \<16 will receive open-label MRM-3379. All participants will participate for 12 weeks of treatment. The study is also intended as a proof-of-concept investigation to evaluate whether MRM-3379 can improve FXS symptoms
Timeline
- Start
- 2025-11-22
- Primary completion
- 2027-10
- Completion
- 2027-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MRM-3379 | Unknown | — | Oral |