SRX246 for Fragile X Syndrome

Not yet recruiting at 2 trial locations

Overseen By Neal G Simon, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Phase 2

Sponsor: Azevan Pharmaceuticals

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for adult males with Fragile X Syndrome who struggle with irritability, agitation, aggression, and self-injury. Participants will be involved in the study for up to 8 months, requiring weekly check-ins and periodic home visits by nurses.

Inclusion Criteria

Stable medication doses for the last month

I am a man aged between 18 and 45.

My behavior issues are severe, as rated by a professional.

Exclusion Criteria

Suicidal behavior

SGPT and SGOT values 2 or more times the upper limit of normal

History of psychosis

What Are the Treatments Tested in This Trial?

Interventions

• SRX246

Trial Overview

The trial is testing SRX246 against a placebo to see if it can reduce aggressive behaviors in participants. The effectiveness of SRX246 will be measured by tracking the frequency of these behaviors over the course of treatment.

How Is the Trial Designed?

Group I: SRX246 Experimental Treatment 1 Intervention

SRX246 will be provided as 120mg capsule to be taken orally, twice per day, once in the morning and once in the evening.

Group II: Placebo Placebo Group 1 Intervention

Placebo will be provided as a matching capsule to be taken orally, twice per day, once in the morning and once in the evening.

Who Is Running the Clinical Trial?

Azevan Pharmaceuticals

Lead Sponsor

Trials

8

Recruited

470+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+