Aggressive Behavior in Fragile X SyndomePhase 2NCT07328529
Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
A Phase 2 study testing SRX246 in people with Aggressive Behavior in Fragile X Syndome, run by Azevan Pharmaceuticals at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Aggressive Behavior in Fragile X Syndome
- What is being tested?
- SRX246
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Medical condition contraindicating study participation
- SGPT and SGOT values 2 or more times the upper limit of normal
- History of psychosis
- Suicidal behavior
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Rush University Medical Center
Chicago, Illinois, 60612
Elizabeth M Berry-Kravis, MD, PhD, 312-942-4036, Elizabeth_Berry-Kravis@rush.edu
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Craig A Erickson, MD, 513-636-6553, craig.erickson@cchmc.org
University of California, Davis, MIND Institute
Sacramento, California, 95817
David R Hessl, PhD, 916-703-0249, drhessl@ucdavis.edu
About this study
Official title: Safety, Tolerability, and Efficacy of SRX246, a Vasopressin 1a Receptor Antagonist, in Aggressive Participants With Fragile X Syndrome
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.
Read more
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
- Conditions
- Aggressive Behavior in Fragile X Syndome
- Being tested
- SRX246, Placebo
- Keywords
- Fragile X Syndrome, SRX246, vasopressin 1a, irritability, agitation, aggression, self-injury
- Medical subject headings
- Fragile X Syndrome, Psychomotor Agitation, Aggression, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRX246Drug
SRX246 120mg capsules for oral administration
PlaceboDrug
Placebo capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| SRX246 | Experimental | SRX246 will be provided as 120mg capsule to be taken orally, twice per day, once in the morning and once in the evening. Receives: Drug: SRX246 |
| Placebo | Placebo comparator | Placebo will be provided as a matching capsule to be taken orally, twice per day, once in the morning and once in the evening. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist
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.
Measured: Over an 8 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive Behavior in Fragile X SyndomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azevan Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328529
- Sponsor's protocol ID
- AVN014
- Other IDs
- CDMRP-PR240390
- Status last verified
- Oct 2026
- First submitted
- 7 Jan 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Efficacy of SRX246, a Vasopressin 1a Receptor Antagonist, in Aggressive Participants With Fragile X Syndrome
- ClinicalTrials.gov ID
- NCT07328529
- Acronym / sponsor ID
- AVN014
- Conditions
- Aggressive Behavior in Fragile X Syndome
- Keywords
- Fragile X Syndrome, SRX246, vasopressin 1a, irritability, agitation, aggression, self-injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Azevan PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRX246 | Experimental | Drug: SRX246SRX246 will be provided as 120mg capsule to be taken orally, twice per day, once in the morning and once in the evening. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be provided as a matching capsule to be taken orally, twice per day, once in the morning and once in the evening. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Medical condition contraindicating study participation
- SGPT and SGOT values 2 or more times the upper limit of normal
- History of psychosis
- Suicidal behavior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRX246SRX246 120mg capsules for oral administration | Drug | SRX246 |
| PlaceboPlacebo capsules for oral administration | Drug | Placebo |
Primary outcome
Aberrant Behavior Checklist
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SRX246 in people with Aggressive Behavior in Fragile X Syndome, run by Azevan Pharmaceuticals at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neal G Simon, PhD (610-610-0100, ngsimon@azevan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist (time frame: Over an 8 month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.