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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-PR240390 | Other Grant/Funding Number | Congressionally Directed Medical Research Programs (CDMRP) |
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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRX246 | Drug | SRX246 120mg capsules for oral administration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Over an 8 month period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neal G Simon, PhD | Contact | 610-610-0100 | ngsimon@azevan.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis, MIND Institute | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D005600 | Fragile X Syndrome |
| D011595 | Psychomotor Agitation |
| D000374 | Aggression |
| D016728 | Self-Injurious Behavior |
| ID | Term |
|---|---|
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C584649 | SRX246 |
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| Drug |
Placebo capsules for oral administration |
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| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
|
| D009422 | Nervous System Diseases |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D040181 | Genetic Diseases, X-Linked |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D020820 | Dyskinesias |
| D011596 | Psychomotor Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |