Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
NCT ID: NCT07328529
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2026-03-31
2028-03-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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SRX246
SRX246 will be provided as 120mg capsule to be taken orally, twice per day, once in the morning and once in the evening.
SRX246
SRX246 120mg capsules for oral administration
Placebo
Placebo will be provided as a matching capsule to be taken orally, twice per day, once in the morning and once in the evening.
Placebo
Placebo capsules for oral administration
Interventions
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SRX246
SRX246 120mg capsules for oral administration
Placebo
Placebo capsules for oral administration
Eligibility Criteria
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Inclusion Criteria
* 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
* SGPT and SGOT values 2 or more times the upper limit of normal
* History of psychosis
* Suicidal behavior
18 Years
45 Years
MALE
No
Sponsors
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Congressionally Directed Medical Research Programs
FED
Azevan Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CDMRP-PR240390
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
AVN014
Identifier Type: -
Identifier Source: org_study_id
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