Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome

Safety, Tolerability, and Efficacy of SRX246, a Vasopressin 1a Receptor Antagonist, in Aggressive Participants With Fragile X Syndrome

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07328529

Enrollment

Registered

2026-01-09

Start date

2026-03-31

Completion date

2028-03-31

Last updated

2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggressive Behavior in Fragile X Syndome

Keywords

Fragile X Syndrome, SRX246, vasopressin 1a, irritability, agitation, aggression, self-injury

Brief 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

Interventions

DRUGSRX246

SRX246 120mg capsules for oral administration

DRUGPlacebo

Placebo capsules for oral administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactNeal G Simon, PhD

ngsimon@azevan.com610-610-0100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026