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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Oral capsule
Oral capsule
Oral capsule
Southwest Autism Research & Resource Center
Phoenix, Arizona, United States
RECRUITINGAmnova Clinical Research, LLC
Irvine, California, United States
RECRUITINGBoston Children's Hospital
Boston, Massachusetts, United States
Incidence and severity of treatment-emergent adverse events and Withdrawal due to adverse events and withdrawal due to adverse events
Time frame: Baseline to Week 12
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Capsules matched to study drug without the active pharmaceutical ingredient
Oral capsule
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
NOT_YET_RECRUITINGSuburban Research Associates
Media, Pennsylvania, United States
RECRUITING