Trial · NCT03062540
Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD
NCT03062540, Phase 3, Terminated, Tonix Pharmaceuticals, Inc.; results first posted 2024-05-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD. Trials, record NCT03062540. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03062540
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD
- NCT number
- NCT03062540
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 358 participants, actual
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Conditions
- PTSD
- Interventions
- TNX-102 SL, Placebo SL Tablet
- First posted
- 2017-02-23
- Last updated
- 2024-05-22
- Results first posted
- 2024-05-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12. | Day 0 and Week 12 | To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) total symptom severity score in a 12-week study. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms. |
| Secondary | Clinical Global Impression - Improvement From Initiation of Treatment (CGI-I) Score After 12 Weeks of Treatment. | Week 12 | To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the CGI-I score after 12 weeks of treatment. Score ranges from 1 to 7. 1 = Very much improved. 2 = Much improved. 3 = Minimally improved. 4 = No change. 5 = Minimally worse. 6 = Much worse. 7 = Very much worse. |
| Secondary | Change From Baseline in the Disruption of Social Life/Leisure Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment. | Day 0, Week 12. | To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of social life/leisure activities assessed with the SDS after 12 weeks of treatment. Score ranges from 0 to 10. Lower scores indicate less disruption to social life/leisure activities. |
| Secondary | Change From Baseline in the Disruption of Work/School Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment. | Day 0, Week 12. | To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of work/school activities assessed with the SDS after 12 weeks of treatment. Score ranges from 0 to 10. Lowers scores indicate less disruption to work/school activities. |
| Secondary | Change From Baseline in Patients' Quality of Sleep Using the Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance Scale After 12 Weeks of Treatment. | Day 0, Week 12. | To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in quality of sleep using the PROMIS Sleep Disturbance scale after 12 weeks of treatment. Raw score is transformed to T-scores using published conversions. T-score ranges from 30 to 80 with lower scores indicating better sleep quality. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12. | Day 0 and Week 12 | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Clinical Global Impression - Improvement From Initiation of Treatment (CGI-I) Score After 12 Weeks of Treatment. | Week 12 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in the Disruption of Social Life/Leisure Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment. | Day 0, Week 12. | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in the Disruption of Work/School Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment. | Day 0, Week 12. | units on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in Patients' Quality of Sleep Using the Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance Scale After 12 Weeks of Treatment. | Day 0, Week 12. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12. | TNX-102 SL Tablet, 5.6 mg | -15.2 | Standard Error 1.90 | units on a scale | |
| Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12. | Placebo SL Tablet | -14.2 | Standard Error 1.80 | units on a scale | |
| Clinical Global Impression - Improvement From Initiation of Treatment (CGI-I) Score After 12 Weeks of Treatment. | TNX-102 SL Tablet, 5.6 mg | 2.6 | Standard Error 0.16 | score on a scale | |
| Clinical Global Impression - Improvement From Initiation of Treatment (CGI-I) Score After 12 Weeks of Treatment. | Placebo SL Tablet | 2.7 | Standard Error 0.15 | score on a scale | |
| Change From Baseline in the Disruption of Social Life/Leisure Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment. | TNX-102 SL Tablet, 5.6 mg | -2.1 | Standard Error 0.38 | units on a scale | |
| Change From Baseline in the Disruption of Social Life/Leisure Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment. | Placebo SL Tablet | -1.7 | Standard Error 0.35 | units on a scale | |
| Change From Baseline in the Disruption of Work/School Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment. | TNX-102 SL Tablet, 5.6 mg | -1.6 | Standard Error 0.46 | units on a scale | |
| Change From Baseline in the Disruption of Work/School Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment. | Placebo SL Tablet | -1.3 | Standard Error 0.41 | units on a scale | |
| Change From Baseline in Patients' Quality of Sleep Using the Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance Scale After 12 Weeks of Treatment. | TNX-102 SL Tablet, 5.6 mg | -9.3 | Standard Error 1.60 | units on a scale | |
| Change From Baseline in Patients' Quality of Sleep Using the Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance Scale After 12 Weeks of Treatment. | Placebo SL Tablet | -6.7 | Standard Error 1.49 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TNX-102 SL Tablet, 5.6 mg | 179 | |
| Overall Study | STARTED | Placebo SL Tablet | 179 | |
| Overall Study | COMPLETED | TNX-102 SL Tablet, 5.6 mg | 110 | |
| Overall Study | COMPLETED | Placebo SL Tablet | 120 | |
| Overall Study | NOT COMPLETED | TNX-102 SL Tablet, 5.6 mg | 69 | |
| Overall Study | NOT COMPLETED | Placebo SL Tablet | 59 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypoaesthesia Oral | Gastrointestinal disorders | TNX-102 SL Tablet, 5.6 mg | 70 | 175 | |
| other | Hypoaesthesia Oral | Gastrointestinal disorders | Placebo SL Tablet | 2 | 176 | |
| other | Paraesthesia Oral | Gastrointestinal disorders | TNX-102 SL Tablet, 5.6 mg | 16 | 175 | |
| other | Paraesthesia Oral | Gastrointestinal disorders | Placebo SL Tablet | 1 | 176 | |
| other | Somnolence | Nervous system disorders | TNX-102 SL Tablet, 5.6 mg | 27 | 175 | |
| other | Somnolence | Nervous system disorders | Placebo SL Tablet | 15 | 176 | |
| other | Product Taste Abnormal | Product Issues | TNX-102 SL Tablet, 5.6 mg | 17 | 175 | |
| other | Product Taste Abnormal | Product Issues | Placebo SL Tablet | 4 | 176 | |
| serious | Suicidal Ideation | Psychiatric disorders | TNX-102 SL Tablet, 5.6 mg | 1 | 175 | |
| serious | Suicidal Ideation | Psychiatric disorders | Placebo SL Tablet | 1 | 176 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TNX-102 SL Tablet, 5.6 mg | 0 | 179 |
| Total, all-cause mortality | Placebo SL Tablet | 0 | 179 |
| Total, other adverse events | TNX-102 SL Tablet, 5.6 mg | 93 | 175 |
| Total, other adverse events | Placebo SL Tablet | 21 | 176 |
| Total, serious adverse events | TNX-102 SL Tablet, 5.6 mg | 3 | 175 |
| Total, serious adverse events | Placebo SL Tablet | 5 | 176 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TNX-102 SL Tablet, 5.6 mg vs Placebo SL Tablet: deaths from any cause | Trial comparisons |
| TNX-102 SL Tablet, 5.6 mg vs Placebo SL Tablet: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03062540
GET https://conductscience.org/api/trials/v1/NCT03062540/events?page=2