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

Status: Recruiting

Researchers are studying an investigational medication called MRM-3379 for males with Fragile X syndrome (FXS), a genetic condition that can affect learning, memory, communication, and behavior. The goal of this study is to evaluate the safety and tolerability of MRM-3379 and explore whether it may help improve cognitive function by supporting brain cell communication. The study will also examine how the body processes the medication.

I'm interested

Sex: Male
Age Group: Not specified
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• male, ages 13-45
• diagnosed with Fragile X syndrome (FXS) confirmed through genetic testing
• able to complete study activities that assess language and thinking abilities
• have a consistent caregiver who is willing and able to provide regular support during the study
• able to swallow tablets or capsules
• see link to clinicaltrials.gov for complete inclusion criteria
Interventions:

Drug: High dose of MRM-3379, Drug: Low dose of MRM-3379, Drug: Low dose of MRM-3379 Open-Label, Drug: Middle Dose of MRM-3379, Drug: Placebo

Conditions:

Rare Diseases, Brain & Nervous System

Keywords:

Fragile X Syndrome, FXS

Study Contact: Rachel Floersch - floer013@umn.edu
Principal Investigator: Amy Esler
Phase: PHASE2
IRB Number: STUDY00027846
See this study on ClinicalTrials.gov

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