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Where local regulations permit inclusion of participants deemed unable to provide informed consent, a legally authorized representative must provide informed consent on the participant's behalf, and the participant must provide assent if applicable.\n* Male, 13-45 years of age (inclusive)\n* Weight ≥30 kg and BMI between 18 and 36 kg\u002Fm2 (inclusive) at the screening visit\n* Diagnosis of FXS with a molecular genetic ≥200 CGG repetitions .\n* Able to perform the PVT and ORRT of the NIH-TCB\n* Have a consistent caregiver(s) who is willing and able to be present regularly and reliably with the participant\n* Able to swallow tablets or capsules\n\nExclusion Criteria:\n\nHistory of or current medical condition other than FXS and related issues that would place the participant at higher risk from study participation","MALE","13 Years","45 Years",{"count":372,"type":373},60,"ESTIMATED","INTERVENTIONAL",[376],"PHASE2","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 \\\u003C16 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",[379],"Fragile X Syndrome",[379,381,382,383,384],"FXS","FMR","Phosphodiesterase 4","PDE4","2026-06-11",{"date":387,"type":388},"2026-06-15","ACTUAL",{"date":390,"type":388},"2025-11-22",{"date":392,"type":373},"2027-10",{"name":5,"class":6},15]