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Evaluate the long-term safety of TNX-102 SL 5.6 mg taken daily at bedtime over an additional 40 weeks in patients with PTSD who have participated in a double-blind lead-in study and completed an initial 12-week open-label extension study (TNX-CY-P303).
This is an open-label, extension trial designed to evaluate safety over 40 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD.
The study will consist of 5 in-clinic study visits, including Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit of the 12-week open-label extension study TNX-CY-P303), followed by in-clinic visits after 7, 16, 28 and 40 weeks of open-label treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNX-102 SL 5.6 mg | Experimental | 2 tablets of TNX-102 SL 2.8 mg taken simultaneously and sublingually (under the tongue) each day at bedtime starting on Day 0 for 40 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNX-102 SL 5.6 mg | Drug | cyclobenzaprine HCl sublingual tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Newly Emergent Adverse Events | Evaluate the incidence of newly emergent adverse events over an additional 40 weeks of treatment with TNX-102 SL 5.6 mg in patients with PTSD who have participated in a double-blinded lead-in study. Adverse events will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized overall and by preferred term and system organ class. Serious AEs and AEs leading to discontinuation of study drug will also be summarized. | 40 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Little Rock | Arkansas | 72211 | United States | ||
| Beverly Hills |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo - TNX-102 SL | This group received placebo in the lead-in double blind study TNX-CY-P301, and received TNX-102-SL 5.6 mg in this open label study TNX-CY-P306. |
| FG001 | TNX-102 SL - TNX-102 SL |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 5, 2019 | Jan 12, 2025 |
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Open-label Study
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| Beverly Hills |
| California |
| 90210 |
| United States |
| Oceanside | Oceanside | California | 92056 | United States |
| Orange | Orange | California | 92868 | United States |
| Temecula | Temecula | California | 92591 | United States |
| Colorado Springs | Colorado Springs | Colorado | 80910 | United States |
| Norwich | Norwich | Connecticut | 06360 | United States |
| Tampa | Tampa | Florida | 33609 | United States |
| Atlanta | Atlanta | Georgia | 30341 | United States |
| New Bedford | New Bedford | Massachusetts | 02740 | United States |
| Las Vegas | Las Vegas | Nevada | 89102 | United States |
| Cedarhurst | Cedarhurst | New York | 11516 | United States |
| New York | New York | New York | 10128 | United States |
| Canton | Canton | Ohio | 44718 | United States |
| Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Oklahoma City | Oklahoma City | Oklahoma | 73103 | United States |
This group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, and received TNX-102 SL 5.6mg in this open label study TNX-CY-P306.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo - TNX-102 SL | This group received placebo in the lead-in double blind study TNX-CY-P301, and received TNX-102-SL 5.6 mg in this open label study TNX-CY-P306. |
| BG001 | TNX-102 SL - TNX-102 SL | This group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, and received TNX-102 SL 5.6mg in this open label study TNX-CY-P306. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Newly Emergent Adverse Events | Evaluate the incidence of newly emergent adverse events over an additional 40 weeks of treatment with TNX-102 SL 5.6 mg in patients with PTSD who have participated in a double-blinded lead-in study. Adverse events will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized overall and by preferred term and system organ class. Serious AEs and AEs leading to discontinuation of study drug will also be summarized. | Posted | Count of Participants | Participants | 40 weeks |
|
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40 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo - TNX-102 SL | This group received placebo in the lead-in double blind study TNX-CY-P301, and received TNX-102-SL 5.6 mg in this open label study TNX-CY-P306. | 0 | 49 | 0 | 49 | 6 | 49 |
| EG001 | TNX-102 SL - TNX-102 SL | This group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, and received TNX-102 SL 5.6mg in this open label study TNX-CY-P306. | 0 | 44 | 0 | 44 | 2 | 44 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoaesthesia oral | Gastrointestinal disorders | Non-systematic Assessment |
|
An industry standard NDA is in place with all investigators.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Sullivan | Tonix Pharmaceuticals | (862) 904-0355 | greg.sullivan@tonixpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 15, 2024 | Jan 12, 2025 | SAP_001.pdf |
| 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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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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