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New treatment option for Fragile X Syndrome
Official title Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)
ClinicalTrials.gov ID: NCT07209462
What this study is testing
What is Low dose of MRM-3379?
Low dose of MRM-3379 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for fragile x syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 45, men only
You may be able to join if
- Willing and able to provide signed informed consent/assent. Where local regulations permit inclusion of participants deemed unable to provide...
- 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
You likely can't join if
- History of or current medical condition other than FXS and related issues that would place the participant at higher risk from study participation
See the full eligibility 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...
- 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
- History of or current medical condition other than FXS and related issues that would place the participant at higher risk from study participation
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Irvine, California, United States
- Orange, California, United States
- Sacramento, California, United States
- Aurora, Colorado, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Cincinnati, Ohio, United States
- Media, Pennsylvania, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 13 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Irvine, California, United States; Orange, California, United States; Sacramento, California, United States; Aurora, Colorado, United States; Miami, Florida, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.