Trial Outcomes & Findings for Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions (NCT NCT02277704)

Last Updated: 2024-06-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

245 participants

Primary outcome timeframe

Day 1, Week 12

Results posted on

2024-06-20

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. Placebo	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	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
Overall Study STARTED	94	101	50
Overall Study COMPLETED	67	71	41
Overall Study NOT COMPLETED	27	30	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=94 Participants 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.	TNX-102 SL, 2.8 mg n=101 Participants 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.	TNX-102 SL, 5.6 mg n=50 Participants 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.	Total n=245 Participants Total of all reporting groups
Age, Continuous Age	31.9 years STANDARD_DEVIATION 6.48 • n=5 Participants	34.5 years STANDARD_DEVIATION 8.11 • n=7 Participants	34.7 years STANDARD_DEVIATION 8.93 • n=5 Participants	33.6 years STANDARD_DEVIATION 7.79 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	92 Participants n=7 Participants	46 Participants n=5 Participants	226 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	15 Participants n=7 Participants	11 Participants n=5 Participants	46 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants	86 Participants n=7 Participants	39 Participants n=5 Participants	199 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	27 Participants n=7 Participants	12 Participants n=5 Participants	60 Participants n=4 Participants
Race (NIH/OMB) White	61 Participants n=5 Participants	68 Participants n=7 Participants	33 Participants n=5 Participants	162 Participants n=4 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1, Week 12

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.	TNX-102 SL, 2.8 mg n=90 Participants 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.	TNX-102 SL, 5.6 mg n=49 Participants 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).	-17.0 units on a scale Standard Error 1.98	-19.2 units on a scale Standard Error 1.99	-21.5 units on a scale Standard Error 2.41

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.	TNX-102 SL, 2.8 mg n=90 Participants 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.	TNX-102 SL, 5.6 mg n=49 Participants 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment	-7.9 units on a scale Standard Error 1.72	-11.1 units on a scale Standard Error 1.74	-11.0 units on a scale Standard Error 2.10

SECONDARY outcome

Timeframe: Week 12

Population: 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.

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

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.	TNX-102 SL, 2.8 mg n=90 Participants 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.	TNX-102 SL, 5.6 mg n=49 Participants 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
Clinician Global Impression - Improvement Scale Responder Rate at Week 12	41 Participants	48 Participants	31 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=92 Participants 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.	TNX-102 SL, 2.8 mg n=90 Participants 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.	TNX-102 SL, 5.6 mg n=49 Participants 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score	-6.4 units on a scale Standard Error 1.11	-7.9 units on a scale Standard Error 1.11	-8.7 units on a scale Standard Error 1.35

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 36 other events

Deaths: 0 deaths

TNX-102 SL, 2.8 mg

Serious events: 0 serious events

Other events: 59 other events

Deaths: 0 deaths

TNX-102 SL, 5.6 mg

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=94 participants at risk 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. Placebo	TNX-102 SL, 2.8 mg n=93 participants at risk 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	TNX-102 SL, 5.6 mg n=50 participants at risk 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime. TNX-102 SL
Immune system disorders Anaphylactic reaction	1.1% 1/94 • Number of events 1 • 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.	0.00% 0/93 • 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.	0.00% 0/50 • 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.
Gastrointestinal disorders Proctitis	0.00% 0/94 • 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.	0.00% 0/93 • 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.	2.0% 1/50 • Number of events 1 • 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.
Infections and infestations Perirectal abscess	0.00% 0/94 • 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.	0.00% 0/93 • 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.	2.0% 1/50 • Number of events 1 • 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.
Nervous system disorders Multiple sclerosis	1.1% 1/94 • Number of events 1 • 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.	0.00% 0/93 • 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.	0.00% 0/50 • 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.
Psychiatric disorders Suicidal Ideation	1.1% 1/94 • Number of events 1 • 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.	0.00% 0/93 • 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.	0.00% 0/50 • 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.

Other adverse events

Other adverse events
Measure	Placebo n=94 participants at risk 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. Placebo	TNX-102 SL, 2.8 mg n=93 participants at risk 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	TNX-102 SL, 5.6 mg n=50 participants at risk 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime. TNX-102 SL
Gastrointestinal disorders Hypoaesthesia Oral	2.1% 2/94 • 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.	38.7% 36/93 • 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.	36.0% 18/50 • 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.
Gastrointestinal disorders Dry mouth	10.6% 10/94 • 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.	4.3% 4/93 • 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.	16.0% 8/50 • 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.
Gastrointestinal disorders paraesthesia oral	3.2% 3/94 • 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.	16.1% 15/93 • 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.	4.0% 2/50 • 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.
Gastrointestinal disorders Glossodynia	1.1% 1/94 • 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.	3.2% 3/93 • 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.	6.0% 3/50 • 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.
Nervous system disorders Somnolence	6.4% 6/94 • 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.	11.8% 11/93 • 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.	16.0% 8/50 • 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.
Nervous system disorders Headache	4.3% 4/94 • 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.	5.4% 5/93 • 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.	12.0% 6/50 • 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.
Nervous system disorders Sedation	1.1% 1/94 • 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.	2.2% 2/93 • 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.	12.0% 6/50 • 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.
Psychiatric disorders Insomnia	8.5% 8/94 • 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.	7.5% 7/93 • 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.	6.0% 3/50 • 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.
Psychiatric disorders Abnormal dreams	5.3% 5/94 • 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.	1.1% 1/93 • 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.	2.0% 1/50 • 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.
Infections and infestations Upper respiratory tract infection	5.3% 5/94 • 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.	3.2% 3/93 • 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.	4.0% 2/50 • 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.
Investigations Weight Increased	5.3% 5/94 • 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.	1.1% 1/93 • 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.	2.0% 1/50 • 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.

Additional Information

Gregory M. Sullivan, Chief Medical Officer

Tonix Pharmaceuticals

Phone: 862-904-0355

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee An industry standard NDA is in place with all investigators.
Publication restrictions are in place

Restriction type: OTHER