Trial · NCT03841773
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD
NCT03841773, Phase 3, Terminated, Tonix Pharmaceuticals, Inc.; results first posted 2025-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD. Trials, record NCT03841773. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03841773
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD
- NCT number
- NCT03841773
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 192 participants, actual
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Conditions
- PTSD
- Interventions
- TNX-102 SL, Placebo SL Tablets
- First posted
- 2019-02-15
- Last updated
- 2025-02-06
- Results first posted
- 2025-02-06
Source ClinicalTrials.gov
Registered outcomes4
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 CAPS-5 Score | Day 1, Week 12 | 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. |
| Secondary | Clinical Global Impression of Severity (CGI-S) | Day 1, Week 12 | 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). |
| Secondary | Sheehan Disability Scale (SDS) | Day 1, Week 12 | 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. |
| Secondary | Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance | Day 1, Week 12 | 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. |
Source ClinicalTrials.gov
Outcomes4
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 CAPS-5 Score | Day 1, Week 12 | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression of Severity (CGI-S) | Day 1, Week 12 | Results are reported for the mITT population. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Sheehan Disability Scale (SDS) | Day 1, Week 12 | Results are reported for the mITT population. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance | Day 1, Week 12 | Results are reported for the mITT population. | T-score | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
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 CAPS-5 Score | Placebo SL Tablet | -18.5 | Standard Error 1.90 | units on a scale | |
| Mean Change From Baseline in the Total CAPS-5 Score | TNX-102 SL Tablet, 5.6 mg | -20.7 | Standard Error 1.97 | units on a scale | |
| Clinical Global Impression of Severity (CGI-S) | Placebo SL Tablet | -1.5 | Standard Error 0.17 | units on a scale | |
| Clinical Global Impression of Severity (CGI-S) | TNX-102 SL Tablet, 5.6 mg | -2.0 | Standard Error 0.18 | units on a scale | |
| Sheehan Disability Scale (SDS) | Placebo SL Tablet | -7.6 | Standard Error 0.97 | units on a scale | |
| Sheehan Disability Scale (SDS) | TNX-102 SL Tablet, 5.6 mg | -9.4 | Standard Error 1.01 | units on a scale | |
| Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance | Placebo SL Tablet | -9.4 | Standard Error 1.51 | T-score | |
| Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance | TNX-102 SL Tablet, 5.6 mg | -13.0 | Standard Error 1.57 | T-score |
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 | Placebo SL Tablet | 93 | |
| Overall Study | STARTED | TNX-102 SL Tablet, 5.6 mg | 99 | |
| Overall Study | COMPLETED | Placebo SL Tablet | 64 | |
| Overall Study | COMPLETED | TNX-102 SL Tablet, 5.6 mg | 59 | |
| Overall Study | NOT COMPLETED | Placebo SL Tablet | 29 | |
| Overall Study | NOT COMPLETED | TNX-102 SL Tablet, 5.6 mg | 40 |
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 | Placebo SL Tablet | 1 | 91 | |
| other | Hypoaesthesia Oral | Gastrointestinal disorders | TNX-102 SL Tablet, 5.6 mg | 28 | 96 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo SL Tablet | 3 | 91 | |
| other | Dry Mouth | Gastrointestinal disorders | TNX-102 SL Tablet, 5.6 mg | 8 | 96 | |
| other | Paraesthesia Oral | Gastrointestinal disorders | Placebo SL Tablet | 1 | 91 | |
| other | Paraesthesia Oral | Gastrointestinal disorders | TNX-102 SL Tablet, 5.6 mg | 7 | 96 | |
| other | Nausea | Gastrointestinal disorders | Placebo SL Tablet | 5 | 91 | |
| other | Nausea | Gastrointestinal disorders | TNX-102 SL Tablet, 5.6 mg | 1 | 96 | |
| other | Tongue Discomfort | Gastrointestinal disorders | Placebo SL Tablet | 0 | 91 | |
| other | Tongue Discomfort | Gastrointestinal disorders | TNX-102 SL Tablet, 5.6 mg | 5 | 96 |
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 | Placebo SL Tablet | 0 | 93 |
| Total, all-cause mortality | TNX-102 SL Tablet, 5.6 mg | 0 | 99 |
| Total, other adverse events | Placebo SL Tablet | 17 | 91 |
| Total, other adverse events | TNX-102 SL Tablet, 5.6 mg | 46 | 96 |
| Total, serious adverse events | Placebo SL Tablet | 2 | 91 |
| Total, serious adverse events | TNX-102 SL Tablet, 5.6 mg | 0 | 96 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03841773
GET https://conductscience.org/api/trials/v1/NCT03841773/events?page=2