Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome (NCT07328529) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
United States80 participantsStarted 2026-03
Plain-language 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
Who can participate
Age range
18 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Medical condition contraindicating study participation
* SGPT and SGOT values 2 or more times the upper limit of normal
* History of psychosis
* Suicidal behavior
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.