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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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

93 participants

Primary outcome timeframe

40 weeks

Results posted on

2025-02-05

Participant Flow

Participant milestones

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

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=5 Participants
34.5 years
STANDARD_DEVIATION 7.91 • n=7 Participants
36.8 years
STANDARD_DEVIATION 8.89 • n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
3 Participants
n=7 Participants
11 Participants
n=5 Participants
Sex: Female, Male
Male
41 Participants
n=5 Participants
41 Participants
n=7 Participants
82 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
8 Participants
n=5 Participants
3 Participants
n=7 Participants
11 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
41 Participants
n=5 Participants
41 Participants
n=7 Participants
82 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
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Asian
3 Participants
n=5 Participants
4 Participants
n=7 Participants
7 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
9 Participants
n=5 Participants
9 Participants
n=7 Participants
18 Participants
n=5 Participants
Race (NIH/OMB)
White
31 Participants
n=5 Participants
26 Participants
n=7 Participants
57 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Region of Enrollment
United States
49 participants
n=5 Participants
44 participants
n=7 Participants
93 participants
n=5 Participants

PRIMARY outcome

Timeframe: 40 weeks

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.

Outcome measures

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

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

TNX-102 SL - TNX-102 SL

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Gregory Sullivan

Tonix Pharmaceuticals

Phone: (862) 904-0355

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