StudyFinder
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.
Sex: Male
Age Group: Not specified
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