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This is a clinical study for adult subjects with Post Traumatic Stress Disorder.
Open label clinical study to evaluate the efficacy of PRX-03140 in reducing PTSD symptoms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRX-03140 | Experimental | PRX-03140 for the treatment of PTSD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRX-03140 | Drug | 50 mg PRX-03140 capsules once daily for 2 weeks. After 2 weeks, the dose will increase to 100mg PRX-03140 once daily for 10 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in adverse events from baseline | adverse events will be evaluated at every visit | weekly for 4 weeks then every 4 weeks until week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in PTSD and mood related symptoms | subjects will fill out PTSD and mood related symptoms questionnaires at each visit to show any changes in symptoms from baseline | weekly for 4 weeks then every 4 weeks until week 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Abernethy, MD | Alachua Government Services, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 5, 2015 | |
| Reset | Nov 2, 2015 | |
| Release | Nov 2, 2015 | |
| Reset | Dec 3, 2015 | |
| Release | Feb 1, 2017 | |
| Reset | Mar 22, 2017 | |
| Release | Apr 4, 2017 | |
| Reset | May 11, 2017 | |
| Release | Apr 3, 2018 | |
| Reset | May 1, 2018 | |
| Release | Sep 13, 2020 | |
| Reset | Oct 7, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 5, 2015 | Nov 2, 2015 | |||
| Nov 2, 2015 |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Dec 3, 2015 |
| Feb 1, 2017 | Mar 22, 2017 |
| Apr 4, 2017 | May 11, 2017 |
| Apr 3, 2018 | May 1, 2018 |
| Sep 13, 2020 | Oct 7, 2020 |