DRUG
SRX246
SRX246 120mg capsules for oral administration
Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
Status
Not yet recruiting
Phase
Phase 2
Enrollment
80
Locations
3
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
Placebo
Placebo capsules for oral administration
Timeline
From registration to results.
First posted
Jan 9, 2026
Study start
Mar 2026
Primary completion
Mar 2027
Study completion
Mar 2028
Results posted
Not reported
Registry updated
Jan 9, 2026
Outcomes
What the study measures.
Primary outcomes
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.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- MALE
- Healthy volunteers
- No
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 locations
3 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
University of California, Davis, MIND Institute
Sacramento, California, United States
Rush University Medical Center
Chicago, Illinois, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Vasopressin.
NCT IDStudyPhase / statusEnrollmentUpdated
Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort Study
First Affiliated Hospital, Sun Yat-Sen University · Liver Neoplasms · Postoperative Complications
Not applicable
Completed
161
2026-07
Mifepristone vs Misoprostol
Montefiore Medical Center · Cervical Preparation
Phase 1
Recruiting
94
2026-07
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Elizabeth Austen Lawson · Vasopressin Deficiency
Phase 1
Recruiting
40
2026-07
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Massachusetts General Hospital · Arginine Vasopressin Deficiency · Oxytocin Deficiency
Early Phase 1
Recruiting
20
2026-07
Randomized Controlled Clinical Study on the Prophylactic Intraoperative Use of Desmopressin in Complex Sellar Region Tumors
Zhaoyun Zhang · Craniopharyngiomas · Pituitary Macroadenoma
Phase 4
Enrolling by invitation
152
2026-07
"SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia
Otsuka Pharmaceutical Development & Commercialization, Inc. · Hyponatremias · Water Intoxication
Phase 3
Completed
205
2026-07
Study of Ascending Levels of Tolvaptan in Hyponatremia
Otsuka Pharmaceutical Development & Commercialization, Inc. · Hyponatremia
Phase 3
Completed
243
2026-07
Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation
Beijing Friendship Hospital · Kidney Transplant · Delayed Graft Function
Not applicable
Active, not recruiting
150
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.