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NCT Number: NCT07328529

Inhibition of Aggressive Behavior in 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

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Key information

Conditions

Aggressive Behavior in Fragile X Syndome Aberrant Motor Behavior in Dementia Aggression Behavior Behavioral Symptoms Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Fragile X Syndrome Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Self-Injurious Behavior Sex Chromosome Disorders Signs and Symptoms Social Behavior X-Linked Intellectual Disability

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of California, Davis, MIND Institute, Sacramento, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SRX246

Drug

SRX246 120mg capsules for oral administration

Placebo

Drug

Placebo capsules for oral administration

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Neal G Simon, PhD

CONTACT

[email protected]

610-610-0100

Sponsors and collaborators

Lead sponsor

Azevan Pharmaceuticals

Industry

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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