This study is not yet accepting patients

Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome

a study on Aggressive Behavior in Fragile X Syndome Fragile X Syndrome

Summary

Eligibility
for males ages 18-45 (full criteria)
Location
at UC Davis
Dates
study started
study ends around

Description

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

Official Title

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

Keywords

Aggressive Behavior in Fragile X Syndome, Fragile X Syndrome, SRX246, vasopressin 1a, irritability, agitation, aggression, self-injury, Psychomotor Agitation, Self-Injurious Behavior

Eligibility

You can join if…

Open to males ages 18-45

  • 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

You CAN'T join if...

  • Medical condition contraindicating study participation
  • SGPT and SGOT values 2 or more times the upper limit of normal
  • History of psychosis
  • Suicidal behavior

Locations

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

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Azevan Pharmaceuticals
ID
NCT07328529
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated