Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07328529
PHASE2

Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome

Sponsor: Azevan Pharmaceuticals

View on ClinicalTrials.gov

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

Key Details

Gender

MALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-03

Completion Date

2028-03

Last Updated

2026-01-09

Healthy Volunteers

No

Interventions

DRUG

SRX246

SRX246 120mg capsules for oral administration

DRUG

Placebo

Placebo capsules for oral administration

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