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NCT07328529 · ClinicalTrials.gov registry record · Phase 2
Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
A Phase 2 study, sponsored by Azevan Pharmaceuticals.
- Not yet
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT07328529: Clinical Trial Phase 2 study, sponsored by Azevan Pharmaceuticals.
NCT07328529 is a Phase 2 study that has not yet begun recruiting, run by Azevan Pharmaceuticals. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07328529, a Phase 2 study, has not yet begun recruiting, sponsored by Azevan Pharmaceuticals.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG SRX246
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-03 |
| Est. Completion | 2028-03 |
| Phase | Phase 2 |
What is known before NCT07328529 opens enrollment
NCT07328529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07328529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07328529 about?
NCT07328529 is a clinical study titled "Inhibition of Aggressive Behavior in 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 SRX2...
What is the current status of trial NCT07328529?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2026-03. Estimated completion is 2028-03.
What interventions are being tested in trial NCT07328529?
The interventions under investigation include: Placebo (DRUG), SRX246 (DRUG).
Who is sponsoring clinical trial NCT07328529?
This trial is sponsored by Azevan Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07328529's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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