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Interim Analysis results
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This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TNX-102 SL Tablet 2.8 mg | Experimental | 2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks. |
|
| Placebo SL Tablet | Placebo Comparator | 2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNX-102 SL | Drug | Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Total CAPS-5 Score | The primary efficacy endpoint is the mean change from baseline (Day 1) in the total CAPS-5 score after 12 weeks of treatment. The CAPS-5 is an updated and validated version of a semi-structured interview that has been designed to assess the essential features of PTSD as defined by the DSM-5. The total score ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms. | Day 1, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Severity (CGI-S) | Change from baseline (Day 1) in CGI-S score at Week 12. CGI-S range from 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients). | Day 1, Week 12 |
| Sheehan Disability Scale (SDS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory M Sullivan, MD | Tonix Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ashild Peters | Phoenix | Arizona | 85012 | United States | ||
| Ashild Peters |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo SL Tablet | 2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks. Placebo SL Tablets: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks |
| FG001 | TNX-102 SL Tablet, 5.6 mg |
| 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 | Dec 23, 2019 | Jan 12, 2025 |
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| Placebo SL Tablets | Drug | Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks |
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Change from baseline in Sheehan Disability Scale (SDS) total score after 12 weeks of treatment comparing the 5.6 mg treatment arm to placebo. The SDS is a self-report questionnaire that was designed to assess the participant's view of the degree to which symptoms have disrupted work/school, social life/leisure activities, and family life/home responsibilities during the previous two weeks. Score ranges from 0 to 30. A score of 0 means the patient is unimpaired, and a score of 30 means the patient is highly impaired.
| Day 1, Week 12 |
| Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance | Change from baseline (Day 1) to Week 12 in the PROMIS Sleep Disturbance scale. The PROMIS Sleep disturbance short form 8a consists of 8 questions on a 5-point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. | Day 1, Week 12 |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Ashild Peters | Rogers | Arkansas | 72758 | United States |
| Ashild Peters | Beverly Hills | California | 90210 | United States |
| Ashild Peters | Oceanside | California | 92056 | United States |
| Ashild Peters | Orange | California | 92868 | United States |
| Ashild Peters | Panorama City | California | 91402 | United States |
| Ashild Peters | Riverside | California | 92506 | United States |
| Ashild Peters | San Diego | California | 92123 | United States |
| Ashild Peters | Temecula | California | 92591 | United States |
| Ashild Peters | Colorado Springs | Colorado | 80910 | United States |
| Ashild Peters | Norwich | Connecticut | 06360 | United States |
| Ashild Peters | Washington D.C. | District of Columbia | 20011 | United States |
| Ashild Peters | Jacksonville | Florida | 32256 | United States |
| Ashild Peters | North Miami | Florida | 33161 | United States |
| Ashild Peters | Orlando | Florida | 32801 | United States |
| Ashild Peters | Tampa | Florida | 33614 | United States |
| Ashild Peters | Alpharetta | Georgia | 30341 | United States |
| Ashild Peters | Lincolnwood | Illinois | 60712 | United States |
| Ashild Peters | Boston | Massachusetts | 02131 | United States |
| Ashild Peters | New Bedford | Massachusetts | 02740 | United States |
| Ashild Peters | Flowood | Mississippi | 39232 | United States |
| Ashild Peters | St Louis | Missouri | 63141 | United States |
| Ashild Peters | Las Vegas | Nevada | 89102 | United States |
| Ashild Peters | Oklahoma City | Oklahoma | 73106 | United States |
| Ashild Peters | Portland | Oregon | 97214 | United States |
| Ashild Peters | Salem | Oregon | 97301 | United States |
| Ashild Peters | Memphis | Tennessee | 38119 | United States |
| Ashild Peters | Austin | Texas | 78737 | United States |
| Ashild Peters | Dallas | Texas | 75231 | United States |
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks. TNX-102 SL: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo SL Tablet | 2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks. Placebo SL Tablets: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks |
| BG001 | TNX-102 SL Tablet, 5.6 mg | 2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks. TNX-102 SL: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks |
| 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 |
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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 |
| ||||||||||||||||
| 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 | Mean Change From Baseline in the Total CAPS-5 Score | The primary efficacy endpoint is the mean change from baseline (Day 1) in the total CAPS-5 score after 12 weeks of treatment. The CAPS-5 is an updated and validated version of a semi-structured interview that has been designed to assess the essential features of PTSD as defined by the DSM-5. The total score ranges from 0 to 80 with higher scores indicating more severe PTSD symptoms. | Results are reported for the mITT population, which includes all randomized participants who have at least a baseline and one post-baseline CAPS-5 assessment. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1, Week 12 |
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| Secondary | Clinical Global Impression of Severity (CGI-S) | Change from baseline (Day 1) in CGI-S score at Week 12. CGI-S range from 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients). | Results are reported for the mITT population. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1, Week 12 |
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| Secondary | Sheehan Disability Scale (SDS) | Change from baseline in Sheehan Disability Scale (SDS) total score after 12 weeks of treatment comparing the 5.6 mg treatment arm to placebo. The SDS is a self-report questionnaire that was designed to assess the participant's view of the degree to which symptoms have disrupted work/school, social life/leisure activities, and family life/home responsibilities during the previous two weeks. Score ranges from 0 to 30. A score of 0 means the patient is unimpaired, and a score of 30 means the patient is highly impaired. | Results are reported for the mITT population. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1, Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance | Change from baseline (Day 1) to Week 12 in the PROMIS Sleep Disturbance scale. The PROMIS Sleep disturbance short form 8a consists of 8 questions on a 5-point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. | Results are reported for the mITT population. | Posted | Least Squares Mean | Standard Error | T-score | Day 1, Week 12 |
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14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
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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 SL Tablet | 2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks. Placebo SL Tablets: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks | 0 | 93 | 2 | 91 | 17 | 91 |
| EG001 | TNX-102 SL Tablet, 5.6 mg | 2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks. TNX-102 SL: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks | 0 | 99 | 0 | 96 | 46 | 96 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystic Acute | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Anaphylactic reaction | Immune system disorders | Non-systematic Assessment |
| ||
| Abcess | Infections and infestations | Non-systematic Assessment |
| ||
| Jaw Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoaesthesia Oral | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Non-systematic Assessment |
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| Paraesthesia Oral | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Tongue Discomfort | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | 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 | Oct 23, 2020 | 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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| 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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| Participants |
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