Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
Status:
NOT_YET_RECRUITING
Trial end date:
2028-03-01
Target enrollment:
Participant gender:
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
Phase:
PHASE2
Details
Lead Sponsor:
Azevan Pharmaceuticals
Collaborator:
Congressionally Directed Medical Research Programs