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Could a pill tame aggression in fragile x? new trial aims to find out

NCT ID NCT07328529

Symptom relief Sponsor: Azevan Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether the drug SRX246 can reduce irritability, aggression, and self-injury in adult males with Fragile X syndrome. Eighty participants will take either SRX246 or a placebo daily for up to 8 months, with regular check-ins by phone or home visits. The goal is to see if the drug improves behavior and is safe to use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SRX246 (a vasopressin 1a receptor antagonist)
What this could lead to
If it works, this could provide a new treatment option to reduce aggressive behaviors in people with Fragile X syndrome, improving daily life for them and their caregivers.
What could go wrong
This is an early Phase 2 trial with only 80 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Aggression fragile X syndrome Psychomotor Agitation Self-Injurious Behavior

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aggressive behavior in fragile X syndome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • University of California, Davis, MIND Institute

    Sacramento, California, 95817, United States