Trial · NCT02277704

Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions

NCT02277704, Phase 2, Completed, Tonix Pharmaceuticals, Inc.; results first posted 2024-06-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions. Trials, record NCT02277704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02277704

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 Subjects With Military-Related PTSD and Related Conditions
NCT number: NCT02277704
Status: Completed
Phases: Phase 2
Enrollment: 245 participants, actual
Lead sponsor: Tonix Pharmaceuticals, Inc.
Conditions: PTSD
Interventions: TNX-102 SL, Placebo
First posted: 2014-10-29
Last updated: 2024-06-20
Results first posted: 2024-06-20

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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).	Day 1, 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.
Secondary	Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment	Day 1, Week 12	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
Secondary	Clinician Global Impression - Improvement Scale Responder Rate at Week 12	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
Secondary	Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score	Day 1, Week 12	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.

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	The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).	Day 1, Week 12	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.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment	Day 1, Week 12	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.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinician Global Impression - Improvement Scale Responder Rate at Week 12	Week 12	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score	Day 1, Week 12	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.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).	Placebo	-17.0	Standard Error 1.98	units on a scale
The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).	TNX-102 SL, 2.8 mg	-19.2	Standard Error 1.99	units on a scale
The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).	TNX-102 SL, 5.6 mg	-21.5	Standard Error 2.41	units on a scale
Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment	Placebo	-7.9	Standard Error 1.72	units on a scale
Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment	TNX-102 SL, 2.8 mg	-11.1	Standard Error 1.74	units on a scale
Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment	TNX-102 SL, 5.6 mg	-11.0	Standard Error 2.10	units on a scale
Clinician Global Impression - Improvement Scale Responder Rate at Week 12	Placebo	41		Participants
Clinician Global Impression - Improvement Scale Responder Rate at Week 12	TNX-102 SL, 2.8 mg	48		Participants
Clinician Global Impression - Improvement Scale Responder Rate at Week 12	TNX-102 SL, 5.6 mg	31		Participants
Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score	Placebo	-6.4	Standard Error 1.11	units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	94
Overall Study	STARTED	TNX-102 SL, 2.8 mg	101
Overall Study	STARTED	TNX-102 SL, 5.6 mg	50
Overall Study	COMPLETED	Placebo	67
Overall Study	COMPLETED	TNX-102 SL, 2.8 mg	71
Overall Study	COMPLETED	TNX-102 SL, 5.6 mg	41
Overall Study	NOT COMPLETED	Placebo	27
Overall Study	NOT COMPLETED	TNX-102 SL, 2.8 mg	30
Overall Study	NOT COMPLETED	TNX-102 SL, 5.6 mg	9

Source ClinicalTrials.gov

Adverse events48

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
other	Hypoaesthesia Oral	Gastrointestinal disorders	Placebo	2	94
other	Hypoaesthesia Oral	Gastrointestinal disorders	TNX-102 SL, 2.8 mg	36	93
other	Hypoaesthesia Oral	Gastrointestinal disorders	TNX-102 SL, 5.6 mg	18	50
other	Dry mouth	Gastrointestinal disorders	Placebo	10	94
other	Dry mouth	Gastrointestinal disorders	TNX-102 SL, 2.8 mg	4	93
other	Dry mouth	Gastrointestinal disorders	TNX-102 SL, 5.6 mg	8	50
other	paraesthesia oral	Gastrointestinal disorders	Placebo	3	94
other	paraesthesia oral	Gastrointestinal disorders	TNX-102 SL, 2.8 mg	15	93
other	paraesthesia oral	Gastrointestinal disorders	TNX-102 SL, 5.6 mg	2	50
other	Glossodynia	Gastrointestinal disorders	Placebo	1	94

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	94
Total, all-cause mortality	TNX-102 SL, 2.8 mg	0	101
Total, all-cause mortality	TNX-102 SL, 5.6 mg	0	50
Total, other adverse events	Placebo	36	94
Total, other adverse events	TNX-102 SL, 2.8 mg	59	93
Total, other adverse events	TNX-102 SL, 5.6 mg	35	50
Total, serious adverse events	Placebo	3	94
Total, serious adverse events	TNX-102 SL, 2.8 mg	0	93
Total, serious adverse events	TNX-102 SL, 5.6 mg	1	50

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33979763	RESULT

Source PubMed

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02277704

GET https://conductscience.org/api/trials/v1/NCT02277704/events?page=2

API reference For AI assistants