MRM-3379 for males with Fragile X Syndrome (BLOOM)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BLOOM is a multicenter, double-blind, randomized, placebo-controlled Phase 2 trial testing three dose levels of MRM-3379 over 12 weeks to characterize safety and tolerability in male participants with molecularly confirmed Fragile X Syndrome. Males aged 16–45 are randomized to low, middle, high dose or placebo, while a separate open-label cohort enrolls males 13–15. Participants must meet weight and BMI criteria, be able to swallow tablets, complete NIH Toolbox tasks (PVT and ORRT), and have a consistent caregiver available for visits. Exploratory measures are collected to provide proof-of-concept data on whether MRM-3379 can improve FXS symptoms.

Why it matters

Who can join: the full rules

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

Where it's running

• Southwest Autism Research & Resource Center
  Phoenix, Arizona, United States Recruiting
• Amnova Clinical Research, LLC
  Irvine, California, United States Recruiting
• Children's Hospital of Orange County - Pediatric Subspecialty
  Orange, California, United States Recruiting
• Uc Davis Mind Institute
  Sacramento, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Neurology
  Miami, Florida, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.