Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM) (NCT07209462)
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of MRM-3379 in Male Participants With Fragile X Syndrome
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Southwest Autism Research & Resource Center — Phoenix, Arizona
Age range: 13 Years to 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- Southwest Autism Research & Resource Center — Phoenix, Arizona
- Amnova Clinical Research, LLC — Irvine, California
- Children's Hospital of Orange County - Pediatric Subspecialty — Orange, California
- Uc Davis Mind Institute — Sacramento, California
- Children's Hospital Colorado — Aurora, Colorado
- Neurology — Miami, Florida
- Emory University - The Emory Clinic - Clifton Road — Atlanta, Georgia
- Rush University Medical Center-Clinical Operation — Chicago, Illinois
- Kennedy Krieger Institute, John Hopkins School of Medicine — Baltimore, Maryland
- Boston Children's Hospital — Boston, Massachusetts
- UMass Memorial Health — Worcester, Massachusetts
- University of Minnesota Department of Medicine — Minneapolis, Minnesota
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Suburban Research Associates — Media, Pennsylvania
- Intermountain Healthcare - Park City Specialty Clinic — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (480) 351-0567
Email: rstark@autismcenter.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Fragile X Syndrome
- Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge — Cincinnati, Ohio
- An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome — Irvine, California
- Open Label Extension to Assess the Long-Term Safety and Tolerability of ZYN002 in Children and Adolescents With FXS — Phoenix, Arizona
- Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Infant — Cincinnati, Ohio
- Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals With Fragile-X Syndrome — Sherbrooke, Quebec
Explore by condition: All Fragile X Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.