Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)
Start Date
11/22/2025
Completion Date
10/1/2027
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
Eligibility Criteria
Age Range: 13 years to 45 years
Interventions
Low dose of MRM-3379
Middle Dose of MRM-3379
High dose of MRM-3379
Placebo
Low dose of MRM-3379 Open-Label
Conditions
Locations
Southwest Autism Research & Resource Center
Phoenix, Arizona 85006
United States
Amnova Clinical Research, LLC
Irvine, California 92604
United States
Children's Hospital of Orange County - Pediatric Subspecialty
Orange, California 92868
United States
Uc Davis Mind Institute
Sacramento, California 95817
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Neurology
Miami, Florida 33136
United States
Emory University - The Emory Clinic - Clifton Road
Atlanta, Georgia 30322
United States
Rush University Medical Center-Clinical Operation
Chicago, Illinois 60612
United States
Kennedy Krieger Institute, John Hopkins School of Medicine
Baltimore, Maryland 21205
United States
Boston Children's Hospital
Boston, Massachusetts 02115
United States
UMass Memorial Health
Worcester, Massachusetts 01655
United States
University of Minnesota Department of Medicine
Minneapolis, Minnesota 55414
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 42229
United States
Suburban Research Associates
Media, Pennsylvania 19063
United States
Intermountain Healthcare - Park City Specialty Clinic
Salt Lake City, Utah 84108
United States