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Stopped early due to inadequate separation on primary efficacy endpoint in the lead-in HONOR study, TNX-CY-P301
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| Name | Class |
|---|---|
| Premier Research | OTHER |
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This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited into this trial are those who have successfully completed the double-blind lead-in study.
The study will consist of 5 study visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit on double-blind treatment), a phone visit after 2 weeks of treatment, and in-clinic visits after 4, 8, and 12 weeks of treatment.
The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.
The secondary objective of the study is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNX-102 SL | Experimental | 2 x TNX-102 SL, 2.8 mg tablets taken daily at bedtime for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNX-102 SL | Drug | 2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Newly Emergent Adverse Events of TNX-102 SL Tablets Taken Daily at Bedtime Over an Additional 12 Weeks in Patients With PTSD Who Have Completed 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score | The CAPS-5 symptom severity 1-week recall version will be administered by qualified and trained clinicians. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms. | Day 1 of TNX-CY-P301 (Week -12 of TNX-CY-P303), Day 1 of TNX-CY-P303, Week 12 of TNX-CY-P303 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise Bedoya | Premier Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Phoenix | Arizona | 85032 | United States | ||
| Rogers |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo - TNX-102 SL | The patients in this group received placebo in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303. |
| 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 | Mar 31, 2017 | Jan 12, 2025 |
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| Rogers |
| Arkansas |
| 72758 |
| United States |
| Beverly Hills | Beverly Hills | California | 90210 | United States |
| Glendale | Glendale | California | 91206 | United States |
| Oakland | Oakland | California | 94607 | United States |
| Oceanside | Oceanside | California | 92056 | United States |
| Orange | Orange | California | 92868 | United States |
| Riverside | Riverside | California | 92506 | United States |
| San Diego | San Diego | California | 92123 | United States |
| San Diego | San Diego | California | 92161 | United States |
| Temecula | Temecula | California | 92591 | United States |
| Colorado Springs | Colorado Springs | Colorado | 80910 | United States |
| Jacksonville | Jacksonville | Florida | 32256 | United States |
| Lake City | Lake City | Florida | 32607 | United States |
| Lauderhill | Lauderhill | Florida | 33319 | United States |
| Tampa | Tampa | Florida | 33609 | United States |
| Atlanta | Atlanta | Georgia | 30341 | United States |
| New Bedford | New Bedford | Massachusetts | 02740 | United States |
| Flowood | Flowood | Mississippi | 39232 | United States |
| Las Vegas | Las Vegas | Nevada | 89102 | United States |
| Berlin | Berlin | New Jersey | 08009 | 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 |
| Dayton | Dayton | Ohio | 45417 | United States |
| Oklahoma City | Oklahoma City | Oklahoma | 73103 | United States |
| Charleston | Charleston | South Carolina | 29407 | United States |
| Austin | Austin | Texas | 78754 | United States |
| Dallas | Dallas | Texas | 75231 | United States |
| Houston | Houston | Texas | 77098 | United States |
| San Antonio | San Antonio | Texas | 78229 | United States |
The patients in this group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo - TNX-102 SL | The patients in this group received placebo in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303. |
| BG001 | TNX-102 SL - TNX-102 SL | The patients in this group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 of TNX-102 SL Tablets Taken Daily at Bedtime Over an Additional 12 Weeks in Patients With PTSD Who Have Completed 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. | Posted | Count of Participants | Participants | 12 weeks |
|
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| ||||||||||||||||||||||||||||||
| Secondary | Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score | The CAPS-5 symptom severity 1-week recall version will be administered by qualified and trained clinicians. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1 of TNX-CY-P301 (Week -12 of TNX-CY-P303), Day 1 of TNX-CY-P303, Week 12 of TNX-CY-P303 |
|
|
12 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 | The patients in this group received placebo in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303. | 0 | 97 | 0 | 97 | 49 | 97 |
| EG001 | TNX-102 SL - TNX-102 SL | The patients in this group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303. | 0 | 93 | 0 | 93 | 19 | 93 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoaesthesia Oral | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Glossodynia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Paraesthesia oral | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Non-systematic Assessment |
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| Product Taste Abnormal | Product Issues | Non-systematic Assessment |
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An industry standard NDA is in place with all investigators.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Sullivan, MD | Tonix Pharmaceuticals | 862-904-0355 | greg.sullivan@tonixpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 26, 2024 | Jan 12, 2025 | SAP_001.pdf |
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| 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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| ID | Term |
|---|---|
| C004704 | cyclobenzaprine |
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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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