Trial Outcomes & Findings for 12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients (NCT NCT03110575)
NCT ID: NCT03110575
Last Updated: 2025-02-06
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
190 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-02-06
Participant Flow
Participant milestones
| Measure |
Placebo - TNX-102 SL
The patients in this group received placebo in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303.
|
TNX-102 SL - TNX-102 SL
The patients in this group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
93
|
|
Overall Study
COMPLETED
|
68
|
67
|
|
Overall Study
NOT COMPLETED
|
29
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients
Baseline characteristics by cohort
| Measure |
Placebo - TNX-102 SL
n=97 Participants
The patients in this group received placebo in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303.
|
TNX-102 SL - TNX-102 SL
n=93 Participants
The patients in this group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 8.19 • n=5 Participants
|
36.1 years
STANDARD_DEVIATION 7.85 • n=7 Participants
|
36.3 years
STANDARD_DEVIATION 8.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
156 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
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=5 Participants
|
93 participants
n=7 Participants
|
190 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksAdverse 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.
Outcome measures
| Measure |
Placebo - TNX-102 SL
n=97 Participants
The patients in this group received placebo in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303.
|
TNX-102 SL - TNX-102 SL
n=93 Participants
The patients in this group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303.
|
|---|---|---|
|
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
|
62 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: Day 1 of TNX-CY-P301 (Week -12 of TNX-CY-P303), Day 1 of TNX-CY-P303, Week 12 of TNX-CY-P303The 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.
Outcome measures
| Measure |
Placebo - TNX-102 SL
n=97 Participants
The patients in this group received placebo in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303.
|
TNX-102 SL - TNX-102 SL
n=93 Participants
The patients in this group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303.
|
|---|---|---|
|
Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score
Change from TNX-CY-P301 baseline
|
-24.5 units on a scale
Standard Error 2.43
|
-24.2 units on a scale
Standard Error 2.64
|
|
Change From Both Baselines in the Total Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Score
Change from TNX-CY-P303 baseline
|
-6.2 units on a scale
Standard Error 1.63
|
-6.2 units on a scale
Standard Error 1.78
|
Adverse Events
Placebo - TNX-102 SL
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
TNX-102 SL - TNX-102 SL
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo - TNX-102 SL
n=97 participants at risk
The patients in this group received placebo in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303.
|
TNX-102 SL - TNX-102 SL
n=93 participants at risk
The patients in this group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303.
|
|---|---|---|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
29.9%
29/97 • 12 Weeks
|
12.9%
12/93 • 12 Weeks
|
|
Gastrointestinal disorders
Glossodynia
|
9.3%
9/97 • 12 Weeks
|
2.2%
2/93 • 12 Weeks
|
|
Gastrointestinal disorders
Paraesthesia oral
|
7.2%
7/97 • 12 Weeks
|
2.2%
2/93 • 12 Weeks
|
|
Nervous system disorders
Somnolence
|
9.3%
9/97 • 12 Weeks
|
8.6%
8/93 • 12 Weeks
|
|
Product Issues
Product Taste Abnormal
|
6.2%
6/97 • 12 Weeks
|
4.3%
4/93 • 12 Weeks
|
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