Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome

Phase 2Not Yet RecruitingNCT07328529

Azevan Pharmaceuticals80 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Aggressive Behavior in Fragile X Syndome

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (3)

University of California, Davis, MIND Institute

Sacramento, California, United States

Rush University Medical Center

Chicago, Illinois, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Aberrant Behavior Checklist

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.

Time frame: Over an 8 month period