Trial · NCT03110575
12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients
NCT03110575, 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. 12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients. Trials, record NCT03110575. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03110575
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients
- NCT number
- NCT03110575
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 190 participants, actual
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Conditions
- PTSD
- Interventions
- TNX-102 SL
- First posted
- 2017-04-12
- Last updated
- 2025-02-06
- Results first posted
- 2025-02-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 12 weeks | 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. |
| Secondary | Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score | Day 1 of TNX-CY-P301 (Week -12 of TNX-CY-P303), Day 1 of TNX-CY-P303, Week 12 of TNX-CY-P303 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score | Day 1 of TNX-CY-P301 (Week -12 of TNX-CY-P303), Day 1 of TNX-CY-P303, Week 12 of TNX-CY-P303 | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Placebo - TNX-102 SL | 62 | Participants | ||
| 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 | TNX-102 SL - TNX-102 SL | 40 | Participants | ||
| Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score | Placebo - TNX-102 SL | Change from TNX-CY-P301 baseline | -24.5 | Standard Error 2.43 | units on a scale |
| Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score | TNX-102 SL - TNX-102 SL | Change from TNX-CY-P301 baseline | -24.2 | Standard Error 2.64 | units on a scale |
| Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score | Placebo - TNX-102 SL | Change from TNX-CY-P303 baseline | -6.2 | Standard Error 1.63 | units on a scale |
| Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score | TNX-102 SL - TNX-102 SL | Change from TNX-CY-P303 baseline | -6.2 | Standard Error 1.78 | 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 | Placebo - TNX-102 SL | 97 | |
| Overall Study | STARTED | TNX-102 SL - TNX-102 SL | 93 | |
| Overall Study | COMPLETED | Placebo - TNX-102 SL | 68 | |
| Overall Study | COMPLETED | TNX-102 SL - TNX-102 SL | 67 | |
| Overall Study | NOT COMPLETED | Placebo - TNX-102 SL | 29 | |
| Overall Study | NOT COMPLETED | TNX-102 SL - TNX-102 SL | 26 |
Source ClinicalTrials.gov
Adverse events10
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 - TNX-102 SL | 29 | 97 | |
| other | Hypoaesthesia Oral | Gastrointestinal disorders | TNX-102 SL - TNX-102 SL | 12 | 93 | |
| other | Glossodynia | Gastrointestinal disorders | Placebo - TNX-102 SL | 9 | 97 | |
| other | Glossodynia | Gastrointestinal disorders | TNX-102 SL - TNX-102 SL | 2 | 93 | |
| other | Paraesthesia oral | Gastrointestinal disorders | Placebo - TNX-102 SL | 7 | 97 | |
| other | Paraesthesia oral | Gastrointestinal disorders | TNX-102 SL - TNX-102 SL | 2 | 93 | |
| other | Somnolence | Nervous system disorders | Placebo - TNX-102 SL | 9 | 97 | |
| other | Somnolence | Nervous system disorders | TNX-102 SL - TNX-102 SL | 8 | 93 | |
| other | Product Taste Abnormal | Product Issues | Placebo - TNX-102 SL | 6 | 97 | |
| other | Product Taste Abnormal | Product Issues | TNX-102 SL - TNX-102 SL | 4 | 93 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo - TNX-102 SL | 0 | 97 |
| Total, all-cause mortality | TNX-102 SL - TNX-102 SL | 0 | 93 |
| Total, other adverse events | Placebo - TNX-102 SL | 49 | 97 |
| Total, other adverse events | TNX-102 SL - TNX-102 SL | 19 | 93 |
| Total, serious adverse events | Placebo - TNX-102 SL | 0 | 97 |
| Total, serious adverse events | TNX-102 SL - TNX-102 SL | 0 | 93 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
TNX-102 SL - TNX-102 SL vs Placebo - TNX-102 SL: 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 | Trial comparisons |
| TNX-102 SL - TNX-102 SL vs Placebo - TNX-102 SL: deaths from any cause | Trial comparisons |
| TNX-102 SL - TNX-102 SL vs Placebo - TNX-102 SL: 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/NCT03110575
GET https://conductscience.org/api/trials/v1/NCT03110575/registered