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SRX246 for Aggressive Behavior in Fragile X Syndrome

This study is testing if a drug called SRX246 can help reduce irritability, agitation, aggression, and self-injury (IAAS) in adult men with Fragile X Syndrome (FXS). Researchers also want to understand the safety of SRX246. You would be given either SRX246 capsules or a placebo (a capsule with no medicine) to see if SRX246 lowers the number of times these behaviors occur. The study is looking for 80 men, aged 18 to 45, who have a confirmed diagnosis of Fragile X Syndrome and a history of aggressive behaviors. The study's status is currently unclear.

Study design
This is an interventional study comparing SRX246 to a placebo. It plans to enroll 80 participants.
What's involved
The primary endpoint, the Aberrant Behavior Checklist, will be measured over an 8-month period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 8 months, based on the primary endpoint timeframe.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07328529

Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome

Not Yet Recruiting
PHASE2Ages 18–45InterventionalTreatment
Azevan Pharmaceuticals
~80 participants
Updated 2026-01-09 on ClinicalTrials.gov
What's tested:SRX246Placebo

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Aberrant Behavior Checklist
Measured over Over an 8 month period

Conditions

Aggressive Behavior in Fragile X Syndome

Explore related trials

Fragile X SyndromeFMR1 Gene

Where it's being run

3 sites across 3 states
California1
Illinois1
Ohio1

Who to contact

Neal G Simon, PhD
[email protected]
610-610-0100
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Aberrant Behavior ChecklistOver an 8 month period

    The Aberrant Behavior Checklist-Community Edition (ABC-C) Irritability subscale - Caregiver rated and then scored using the using the FXS-specific factoring system (ABCFX). Responses will be rated using a scale ranging from 0=not a problem to 3=severe problem.