Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of MRM-3379 in Male Participants With Fragile X Syndrome

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

Age range

13–45 years

Sex

Male

Healthy volunteers

No

Interventions

• Drug
  Low dose of MRM-3379

  Oral capsule

• Drug
  Middle Dose of MRM-3379

  Oral capsule

• Drug
  High dose of MRM-3379

  Oral capsule

• Drug
  Placebo

  Capsules matched to study drug without the active pharmaceutical ingredient

• Drug
  Low dose of MRM-3379 Open-Label

  Oral capsule

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