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Not yet recruiting NCT07328529

Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome

Phase II Interventional Aggressive Behavior in Fragile X Syndome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SRX246, Placebo.
Who it may be relevant to
Registry conditions: Aggressive Behavior in Fragile X Syndome. Basic parameters: 18 years — 45 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Drug SRX246
    SRX246 120mg capsules for oral administration
  • Drug Placebo
    Placebo capsules for oral administration

Primary outcome measures

  • Aberrant Behavior Checklist [Time frame: Over an 8 month period]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • University of California, Davis, MIND Institute — Sacramento
  • Rush University Medical Center — Chicago
  • Cincinnati Children's Hospital — Cincinnati

Identifiers

NCT: NCT07328529 · AVN014 · CDMRP-PR240390

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗