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This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL -a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible subjects will return regularly to the study clinic for weekly or biweekly visits for assessments of efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. |
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| TNX-102 SL, 2.8 mg | Active Comparator | 1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. |
|
| TNX-102 SL, 5.6 mg | Active Comparator | 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNX-102 SL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12). | The mean change from baseline (Visit 2) in the Total CAPS-5 score after 12 weeks of treatment evaluated at Visit 9 (Week 12). The primary efficacy comparison will be the change from baseline in total CAPS-5 score for the 2.8 mg treatment arm compared to placebo. CAPS-5 score ranges from 0-80 with lower scores indicating less severe PTSD symptoms. | Day 1, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment | Change from baseline in patients' quality of sleep using the PROMIS (Patient -Reported Outcome Measurement Information System) Sleep Disturbance scale after 12 weeks of treatment comparing the 2.8 mg treatment arm to placebo. Raw scores are converted to T-scores using published conversion tables. Sleep Disturbance T-score ranges from 28.9 to 76.5. Lower scores indicate less sleep disturbance |
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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 |
|---|---|---|---|---|---|---|
| Tuscaloosa VA Medical Center | Tuscaloosa | Alabama | 35404 | United States | ||
| Noesis Pharma |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33979763 | Result | Sullivan GM, Gendreau RM, Gendreau J, Peters P, Peters A, Engels J, Daugherty BL, Vaughn B, Weathers FW, Lederman S. Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response. Psychiatry Res. 2021 Jul;301:113974. doi: 10.1016/j.psychres.2021.113974. Epub 2021 Apr 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. Placebo |
| FG001 | TNX-102 SL, 2.8 mg | 1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. TNX-102 SL Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
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| Day 1, Week 12 |
| Clinician Global Impression - Improvement Scale Responder Rate at Week 12 | Responder rates in CGI-I (Clinician Global Impression - Improvement Scale) after 12 weeks of treatment comparing the 2.8 mg treatment arm to placebo. Responder rate is defined as the number of patients scored as either a 1 or 2 on CGI-I at Week 12. The score ranges from 1 to 7 with the following anchors for each score:1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse | Week 12 |
| Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score | Mean Change from Baseline in SDS Total Score at Week 12. 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 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Sun Valley Research Center | Imperial | California | 92251 | United States |
| National City | National City | California | 91950 | United States |
| Excell Research, Inc | Oceanside | California | 92506 | United States |
| Neuropsychiatric Research Center of Orange County | Orange | California | 92868 | United States |
| CITRIALS | Riverside | California | 92506 | United States |
| Veteran Affairs, San Diego Health Care System | San Diego | California | 92161 | United States |
| Cns, Inc. | Torrance | California | 90502 | United States |
| Sarkis Clinical Trials | Lake City | Florida | 32025 | United States |
| Compass Research North, LLC | Leesburg | Florida | 34748 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Atlanta Center For Medical Research | Atlanta | Georgia | 30308 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Novex Clinical Research | New Bedford | Massachusetts | 02740 | United States |
| Premier Psychiatric Research Institute, Inc. | Lincoln | Nebraska | 68526 | United States |
| Altea Research | Las Vegas | Nevada | 89102 | United States |
| Cedarhurst | Cedarhurst | New York | 11516 | United States |
| Cincinnati | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| FG002 | TNX-102 SL, 5.6 mg | 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime. TNX-102 SL |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. |
| BG001 | TNX-102 SL, 2.8 mg | 1 x TNX-102 SL 2.8 mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. |
| BG002 | TNX-102 SL, 5.6 mg | 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime. |
| BG003 | 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 |
|
| 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 | The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12). | The mean change from baseline (Visit 2) in the Total CAPS-5 score after 12 weeks of treatment evaluated at Visit 9 (Week 12). The primary efficacy comparison will be the change from baseline in total CAPS-5 score for the 2.8 mg treatment arm compared to placebo. CAPS-5 score ranges from 0-80 with lower scores indicating less severe PTSD symptoms. | Results are reported for patients in mITT population (included all patients who were randomized, had a baseline CAPS-5 and at least one post-baseline CAPS-5). At Week 12 or last visit for subjects discontinuing early, values recorded more than 7 days after the last recorded dose are censored. Subjects that are lost to follow up or do not have a last dose date recorded have the day before their final visit imputed as the last dose date. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1, Week 12 |
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| Secondary | Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment | Change from baseline in patients' quality of sleep using the PROMIS (Patient -Reported Outcome Measurement Information System) Sleep Disturbance scale after 12 weeks of treatment comparing the 2.8 mg treatment arm to placebo. Raw scores are converted to T-scores using published conversion tables. Sleep Disturbance T-score ranges from 28.9 to 76.5. Lower scores indicate less sleep disturbance | Results are reported for patients in mITT population (included all patients who were randomized, had a baseline CAPS-5 and at least one post-baseline CAPS-5). At Week 12 or last visit for subjects discontinuing early, values recorded more than 7 days after the last recorded dose are censored. Subjects that are lost to follow up or do not have a last dose date recorded have the day before their final visit imputed as the last dose date. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1, Week 12 |
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| Secondary | Clinician Global Impression - Improvement Scale Responder Rate at Week 12 | Responder rates in CGI-I (Clinician Global Impression - Improvement Scale) after 12 weeks of treatment comparing the 2.8 mg treatment arm to placebo. Responder rate is defined as the number of patients scored as either a 1 or 2 on CGI-I at Week 12. The score ranges from 1 to 7 with the following anchors for each score:1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse | Results are reported for patients in mITT population (included all patients who were randomized, had a baseline CAPS-5 and at least one post-baseline CAPS-5). Patients without CGI-I data at Week 12 were considered as being non-responders. | Posted | Count of Participants | Participants | Week 12 |
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| Secondary | Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score | Mean Change from Baseline in SDS Total Score at Week 12. 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 patients in mITT population (included all patients who were randomized, had a baseline CAPS-5 and at least one post-baseline CAPS-5). At Week 12 or last visit for subjects discontinuing early, values recorded more than 7 days after the last recorded dose are censored. Subjects that are lost to follow up or do not have a last dose date recorded have the day before their final visit imputed as the last dose date. | Posted | Least Squares Mean | Standard Error | units on a scale | Day 1, Week 12 |
|
12 weeks
All adverse events are reported for the Safety Population, which includes patients who took at least one dose of study medication.
All-cause mortality is reported for all patients.
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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 | 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. Placebo | 0 | 94 | 3 | 94 | 36 | 94 |
| EG001 | TNX-102 SL, 2.8 mg | 1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. TNX-102 SL Placebo | 0 | 101 | 0 | 93 | 59 | 93 |
| EG002 | TNX-102 SL, 5.6 mg | 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime. TNX-102 SL | 0 | 50 | 1 | 50 | 35 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | Non-systematic Assessment |
| ||
| Proctitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Perirectal abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Multiple sclerosis | Nervous system disorders | Non-systematic Assessment | acute episode of multiple sclerosis |
| |
| Suicidal Ideation | Psychiatric disorders | 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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| Glossodynia | Gastrointestinal disorders | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Sedation | Nervous system disorders | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Weight Increased | Investigations | Systematic Assessment |
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An industry standard NDA is in place with all investigators.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory M. Sullivan, Chief Medical Officer | Tonix Pharmaceuticals | 862-904-0355 | greg.sullivan@tonixpharma.com |
| 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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| TNX-102 SL, 5.6 mg |
2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime. TNX-102 SL |
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