Trial Outcomes & Findings for A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD (NCT NCT03841773)
NCT ID: NCT03841773
Last Updated: 2025-02-06
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
192 participants
Primary outcome timeframe
Day 1, Week 12
Results posted on
2025-02-06
Participant Flow
Participant milestones
| Measure |
Placebo SL Tablet
2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablets: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
TNX-102 SL Tablet, 5.6 mg
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
99
|
|
Overall Study
COMPLETED
|
64
|
59
|
|
Overall Study
NOT COMPLETED
|
29
|
40
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD
Baseline characteristics by cohort
| Measure |
Placebo SL Tablet
n=93 Participants
2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablets: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
TNX-102 SL Tablet, 5.6 mg
n=99 Participants
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 10.67 • n=99 Participants
|
39.8 years
STANDARD_DEVIATION 11.61 • n=107 Participants
|
38.5 years
STANDARD_DEVIATION 11.16 • n=206 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
152 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
157 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
144 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=99 Participants
|
99 participants
n=107 Participants
|
192 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1, Week 12Population: 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.
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.
Outcome measures
| Measure |
Placebo SL Tablet
n=83 Participants
2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablets: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
TNX-102 SL Tablet, 5.6 mg
n=80 Participants
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
|---|---|---|
|
Mean Change From Baseline in the Total CAPS-5 Score
|
-18.5 units on a scale
Standard Error 1.90
|
-20.7 units on a scale
Standard Error 1.97
|
SECONDARY outcome
Timeframe: Day 1, Week 12Population: Results are reported for the mITT population.
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).
Outcome measures
| Measure |
Placebo SL Tablet
n=83 Participants
2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablets: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
TNX-102 SL Tablet, 5.6 mg
n=80 Participants
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
|---|---|---|
|
Clinical Global Impression of Severity (CGI-S)
|
-1.5 units on a scale
Standard Error 0.17
|
-2.0 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Day 1, Week 12Population: Results are reported for the mITT population.
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.
Outcome measures
| Measure |
Placebo SL Tablet
n=83 Participants
2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablets: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
TNX-102 SL Tablet, 5.6 mg
n=80 Participants
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
|---|---|---|
|
Sheehan Disability Scale (SDS)
|
-7.6 units on a scale
Standard Error 0.97
|
-9.4 units on a scale
Standard Error 1.01
|
SECONDARY outcome
Timeframe: Day 1, Week 12Population: Results are reported for the mITT population.
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.
Outcome measures
| Measure |
Placebo SL Tablet
n=83 Participants
2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablets: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
TNX-102 SL Tablet, 5.6 mg
n=80 Participants
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
|---|---|---|
|
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance
|
-9.4 T-score
Standard Error 1.51
|
-13.0 T-score
Standard Error 1.57
|
Adverse Events
Placebo SL Tablet
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
TNX-102 SL Tablet, 5.6 mg
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo SL Tablet
n=91 participants at risk
2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablets: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
TNX-102 SL Tablet, 5.6 mg
n=96 participants at risk
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystic Acute
|
1.1%
1/91 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
0.00%
0/96 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
1.1%
1/91 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
0.00%
0/96 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Abcess
|
1.1%
1/91 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
0.00%
0/96 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Jaw Fracture
|
1.1%
1/91 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
0.00%
0/96 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo SL Tablet
n=91 participants at risk
2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablets: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
TNX-102 SL Tablet, 5.6 mg
n=96 participants at risk
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
1.1%
1/91 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
29.2%
28/96 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry Mouth
|
3.3%
3/91 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
8.3%
8/96 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
1.1%
1/91 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
7.3%
7/96 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.5%
5/91 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
1.0%
1/96 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Tongue Discomfort
|
0.00%
0/91 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
5.2%
5/96 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
4/91 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
5.2%
5/96 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
5.5%
5/91 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
3.1%
3/96 • 14 weeks
Al Cause Mortality is reported for all participants. AEs and SAEs are reported for the Safety population, which includes participants who took at least 1 dose of study drug.
|
Additional Information
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