Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM) (NCT07209462) | Clinical Trial Compass
RecruitingPhase 2
Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)
United States60 participantsStarted 2025-11-22
Plain-language 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
Who can participate
Age range13 Years – 45 Years
SexMALE
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Inclusion Criteria:
* Willing and able to provide signed informed consent/assent. 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.
* Male, 13-45 years of age (inclusive)
* Weight ≥30 kg and BMI between 18 and 36 kg/m2 (inclusive) at the screening visit
* Diagnosis of FXS with a molecular genetic ≥200 CGG repetitions .
* Able to perform the PVT and ORRT of the NIH-TCB
* Have a consistent caregiver(s) who is willing and able to be present regularly and reliably with the participant
* Able to swallow tablets or capsules
Exclusion Criteria:
History of or current medical condition other than FXS and related issues that would place the participant at higher risk from study participation
What they're measuring
1
Incidence and severity of treatment-emergent adverse events and Withdrawal due to adverse events and withdrawal due to adverse events