Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

SRX246: SRX246 120mg capsules for oral administration

Placebo: Placebo capsules for oral administration

Study 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

Primary outcome measure(s)

• Aberrant Behavior Checklist — 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.

Trial sites (3)