Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Aggressive Behavior in Fragile X Syndome

In brief

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

Key facts

Study ID

NCT07328529

Run by

Azevan Pharmaceuticals

People needed

80

Starts

2026-03-01

Expected to finish

2028-03-01

Last updated by the study team

2026-01-09

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Biological male, age 18 to 45 years inclusive
• Molecular genetic confirmation of the full Fragile X messenger ribonucleoprotein mutation (≥200 CGG repetitions)
• IAAS symptoms leading to a CGI-S score for Disruptive Behavior of 5 or more
• Reported history of aggression based on the CMAI-Agg subscale (average score >22) and an average associated disruptiveness scale of at least 3.
• IQ < 70
• Stable medication doses for the last month
• Has a caregiver who lives with or spends extensive time with the participant most days and can report behavioral symptoms
• Must be able to swallow study drug capsules whole

You may not qualify if…

• Medical condition contraindicating study participation
• SGPT and SGOT values 2 or more times the upper limit of normal
• History of psychosis
• Suicidal behavior

Where it is running

• 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

Full record on ClinicalTrials.gov

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