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Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
Sponsor: Azevan Pharmaceuticals
Summary
The goal of this clinical trial is to learn if drug SRX246 works to treat irritability, agitation, aggression and self-injury (IAAS) behaviors in adult males with Fragile X Syndrome (FXS). It will also learn about the safety of drug SRX246. The main questions it aims to answer are: * Does drug SRX246 lower the number of times participants experience IAAS behaviors? * What medical problems do participants have when taking drug SRX246? Researchers will compare drug SRX246 to a placebo (a look-alike substance that contains no drug) to see if drug SRX246 works to treat IAAS behaviors. Participants will: * Take drug SRX246 or a placebo every day for up to 8 months * Have weekly checkups by phone or video to answer study questions * Have periodically scheduled home visits by nurses to conduct medical check-ups and tests * Keep a diary of their symptoms
Official title: Safety, Tolerability, and Efficacy of SRX246, a Vasopressin 1a Receptor Antagonist, in Aggressive Participants With Fragile X Syndrome
Key Details
Gender
MALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-03
Completion Date
2028-03
Last Updated
2026-01-09
Healthy Volunteers
No
Conditions
Interventions
SRX246
SRX246 120mg capsules for oral administration
Placebo
Placebo capsules for oral administration
Locations (3)
University of California, Davis, MIND Institute
Sacramento, California, United States
Rush University Medical Center
Chicago, Illinois, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States