Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome

January 8, 2026 updated by: Azevan Pharmaceuticals

Safety, Tolerability, and Efficacy of SRX246, a Vasopressin 1a Receptor Antagonist, in Aggressive Participants With Fragile X Syndrome

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis, MIND Institute
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SRX246
SRX246 will be provided as 120mg capsule to be taken orally, twice per day, once in the morning and once in the evening.
Drug: SRX246
SRX246 120mg capsules for oral administration
Placebo Comparator: Placebo
Placebo will be provided as a matching capsule to be taken orally, twice per day, once in the morning and once in the evening.
Drug: Placebo
Placebo capsules for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aberrant Behavior Checklist
Time Frame: Over 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.
Over an 8 month period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azevan Pharmaceuticals

Collaborators

Congressionally Directed Medical Research Programs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVN014
  • CDMRP-PR240390 (Other Grant/Funding Number: Congressionally Directed Medical Research Programs (CDMRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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