Trial Outcomes & Findings for Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD (NCT NCT03062540)
NCT ID: NCT03062540
Last Updated: 2024-05-22
Results Overview
To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) total symptom severity score in a 12-week study. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
358 participants
Primary outcome timeframe
Day 0 and Week 12
Results posted on
2024-05-22
Participant Flow
Participant milestones
| Measure |
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 each day at bedtime starting on Day 0 for 12 weeks
|
Placebo SL Tablet
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
179
|
179
|
|
Overall Study
COMPLETED
|
110
|
120
|
|
Overall Study
NOT COMPLETED
|
69
|
59
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD
Baseline characteristics by cohort
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=179 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 each day at bedtime starting on Day 0 for 12 weeks
|
Placebo SL Tablet
n=179 Participants
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
|
Total
n=358 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 8.21 • n=5 Participants
|
35.9 years
STANDARD_DEVIATION 7.69 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 7.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
164 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
289 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
179 participants
n=5 Participants
|
179 participants
n=7 Participants
|
358 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Week 12To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) total symptom severity score in a 12-week study. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms.
Outcome measures
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=125 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 each day at bedtime starting on Day 0 for 12 weeks
|
Placebo SL Tablet
n=127 Participants
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
|
|---|---|---|
|
Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12.
|
-15.2 units on a scale
Standard Error 1.90
|
-14.2 units on a scale
Standard Error 1.80
|
SECONDARY outcome
Timeframe: Week 12To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the CGI-I score after 12 weeks of treatment. Score ranges from 1 to 7. 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
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=100 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 each day at bedtime starting on Day 0 for 12 weeks
|
Placebo SL Tablet
n=106 Participants
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
|
|---|---|---|
|
Clinical Global Impression - Improvement From Initiation of Treatment (CGI-I) Score After 12 Weeks of Treatment.
|
2.6 score on a scale
Standard Error 0.16
|
2.7 score on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Day 0, Week 12.To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of social life/leisure activities assessed with the SDS after 12 weeks of treatment. Score ranges from 0 to 10. Lower scores indicate less disruption to social life/leisure activities.
Outcome measures
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=100 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 each day at bedtime starting on Day 0 for 12 weeks
|
Placebo SL Tablet
n=106 Participants
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
|
|---|---|---|
|
Change From Baseline in the Disruption of Social Life/Leisure Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment.
|
-2.1 units on a scale
Standard Error 0.38
|
-1.7 units on a scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Day 0, Week 12.To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of work/school activities assessed with the SDS after 12 weeks of treatment. Score ranges from 0 to 10. Lowers scores indicate less disruption to work/school activities.
Outcome measures
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=77 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 each day at bedtime starting on Day 0 for 12 weeks
|
Placebo SL Tablet
n=84 Participants
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
|
|---|---|---|
|
Change From Baseline in the Disruption of Work/School Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment.
|
-1.6 units on a scale
Standard Error 0.46
|
-1.3 units on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Day 0, Week 12.To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in quality of sleep using the PROMIS Sleep Disturbance scale after 12 weeks of treatment. Raw score is transformed to T-scores using published conversions. T-score ranges from 30 to 80 with lower scores indicating better sleep quality.
Outcome measures
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=100 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 each day at bedtime starting on Day 0 for 12 weeks
|
Placebo SL Tablet
n=105 Participants
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
|
|---|---|---|
|
Change From Baseline in Patients' Quality of Sleep Using the Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance Scale After 12 Weeks of Treatment.
|
-9.3 units on a scale
Standard Error 1.60
|
-6.7 units on a scale
Standard Error 1.49
|
Adverse Events
TNX-102 SL Tablet, 5.6 mg
Serious events: 3 serious events
Other events: 93 other events
Deaths: 0 deaths
Placebo SL Tablet
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=175 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 each day at bedtime starting on Day 0 for 12 weeks
|
Placebo SL Tablet
n=176 participants at risk
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.57%
1/175 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
0.57%
1/176 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.57%
1/175 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
0.00%
0/176 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/175 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
0.57%
1/176 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/175 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
0.57%
1/176 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/175 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
0.57%
1/176 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.57%
1/175 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
0.00%
0/176 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/175 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
0.57%
1/176 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
Other adverse events
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=175 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 each day at bedtime starting on Day 0 for 12 weeks
|
Placebo SL Tablet
n=176 participants at risk
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
40.0%
70/175 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
1.1%
2/176 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
9.1%
16/175 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
0.57%
1/176 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
|
Nervous system disorders
Somnolence
|
15.4%
27/175 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
8.5%
15/176 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
|
Product Issues
Product Taste Abnormal
|
9.7%
17/175 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
2.3%
4/176 • 12 weeks
The denominator used for calculating adverse event frequencies was the number of patients confirmed to have taken at least one dose of study medication. Therefore, the denominator used for calculating the frequency differs from the total number of enrolled patients. All-cause mortality was calculated using all patients as the denominator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee An industry standard NDA is in place with all study investigators.
- Publication restrictions are in place
Restriction type: OTHER