Safety, Tolerability, and Efficacy of SRX246, a Vasopressin 1a Receptor Antagonist, in Aggressive Participants With Fragile X Syndrome
Azevan Pharmaceuticals
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
Eligibility
- Age range
- 18–45 years
- Sex
- Male
- Healthy volunteers
- No
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 a…
Interventions
- DrugSRX246
SRX246 120mg capsules for oral administration
- DrugPlacebo
Placebo capsules for oral administration
Locations (3)
- University of California, Davis, MIND InstituteSacramento, California
- Rush University Medical CenterChicago, Illinois
- Cincinnati Children's HospitalCincinnati, Ohio