NCT07328529 · Phase 2 · NOT YET RECRUITING
Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
This trial tests a daily capsule called SRX246 against a placebo to see whether it reduces irritability, agitation, aggression and self-injury in adult men with Fragile X Syndrome. It also tracks side effects. It is a Phase 2 trial, meaning researchers are still testing whether it works and is safe. It is not proven or approved.
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're excluded if
- Medical condition contraindicating study participation
- SGPT and SGOT values 2 or more times the upper limit of normal
- History of psychosis
- Suicidal behavior
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-01-09