ClinicalTrials.gov record NCT07328529

Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old to 45 years old
SexMale
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2 randomized, quadruple-masked crossover study tests the drug SRX246 against placebo in adult males with Fragile X Syndrome who have irritability, agitation, aggression, or self-injury. Participants take study capsules twice daily and are followed for up to 8 months with weekly phone/video check-ins, periodic home nurse visits, and a symptom diary. The study will collect information on behavioral effects and medical safety while taking SRX246.

What it is studying. Whether SRX246 affects irritability, agitation, aggression, and self-injury compared with placebo, and what medical problems occur during treatment.

What the researchers hope to learn. To measure SRX246's effect on irritability and related behaviors using the Fragile X–specific Aberrant Behavior Checklist irritability subscale over an 8-month period, and to assess safety and tolerability of SRX246.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • SRX246
  • Placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will be randomly assigned in a masked crossover to receive SRX246 or matching placebo capsules taken orally twice daily and will take study medication for up to 8 months. They will have weekly phone or video checkups, periodic home visits by nurses for medical checks and tests, and will keep a diary of their symptoms. Caregivers will be asked to report on behaviors.

How the study is structured. Participants are randomly assigned in a crossover design so each person receives SRX246 and placebo in different treatment periods; the trial is quadruple-masked (participant, caregiver, investigator, and outcomes assessor). SRX246 is provided as 120 mg oral capsules taken twice daily, with follow-up by weekly remote check-ins and periodic home nurse visits over about 8 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on fragile X syndrome

Clinical trials20 trials listed for fragile X syndromeEvery trial the registry lists for fragile X syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in fragile X syndrome researchLatest monthly update: September 2026. Includes: Multiple behavior challenges. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
March 2026 (estimated)
Primary completion
March 2027 (estimated)
Study completion
March 2028 (estimated)
Target enrollment
80 participants (estimated)
Last updated on registry
Jan 9, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Azevan Pharmaceuticals
Collaborators
  • Congressionally Directed Medical Research Programs

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (3)

Terms used on this page · explanations by MedicalUpdates.ai

placebo
A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
study drug
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
upper limit of normal
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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