Trial Outcomes & Findings for A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD (NCT NCT03508700)
NCT ID: NCT03508700
Last Updated: 2025-02-05
Results Overview
Evaluate the incidence of newly emergent adverse events over an additional 40 weeks of treatment with TNX-102 SL 5.6 mg in patients with PTSD who have participated in a double-blinded lead-in study. 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. Serious AEs and AEs leading to discontinuation of study drug will also be summarized.
COMPLETED
PHASE3
93 participants
40 weeks
2025-02-05
Participant Flow
Participant milestones
| Measure |
Placebo - TNX-102 SL
This group received placebo in the lead-in double blind study TNX-CY-P301, and received TNX-102-SL 5.6 mg in this open label study TNX-CY-P306.
|
TNX-102 SL - TNX-102 SL
This group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, and received TNX-102 SL 5.6mg in this open label study TNX-CY-P306.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
44
|
|
Overall Study
COMPLETED
|
28
|
29
|
|
Overall Study
NOT COMPLETED
|
21
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD
Baseline characteristics by cohort
| Measure |
Placebo - TNX-102 SL
n=49 Participants
This group received placebo in the lead-in double blind study TNX-CY-P301, and received TNX-102-SL 5.6 mg in this open label study TNX-CY-P306.
|
TNX-102 SL - TNX-102 SL
n=44 Participants
This group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, and received TNX-102 SL 5.6mg in this open label study TNX-CY-P306.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.8 years
STANDARD_DEVIATION 9.29 • n=99 Participants
|
34.5 years
STANDARD_DEVIATION 7.91 • n=107 Participants
|
36.8 years
STANDARD_DEVIATION 8.89 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
82 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
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=99 Participants
|
44 participants
n=107 Participants
|
93 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 40 weeksEvaluate the incidence of newly emergent adverse events over an additional 40 weeks of treatment with TNX-102 SL 5.6 mg in patients with PTSD who have participated in a double-blinded lead-in study. 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. Serious AEs and AEs leading to discontinuation of study drug will also be summarized.
Outcome measures
| Measure |
Placebo - TNX-102 SL
n=49 Participants
This group received placebo in the lead-in double blind study TNX-CY-P301, and received TNX-102-SL 5.6 mg in this open label study TNX-CY-P306.
|
TNX-102 SL - TNX-102 SL
n=44 Participants
This group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, and received TNX-102 SL 5.6mg in this open label study TNX-CY-P306.
|
|---|---|---|
|
Incidence of Newly Emergent Adverse Events
|
26 Participants
|
19 Participants
|
Adverse Events
Placebo - TNX-102 SL
TNX-102 SL - TNX-102 SL
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo - TNX-102 SL
n=49 participants at risk
This group received placebo in the lead-in double blind study TNX-CY-P301, and received TNX-102-SL 5.6 mg in this open label study TNX-CY-P306.
|
TNX-102 SL - TNX-102 SL
n=44 participants at risk
This group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, and received TNX-102 SL 5.6mg in this open label study TNX-CY-P306.
|
|---|---|---|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
12.2%
6/49 • 40 weeks
|
4.5%
2/44 • 40 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