Trial Outcomes & Findings for Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions (NCT NCT02421679)
NCT ID: NCT02421679
Last Updated: 2025-02-06
Results Overview
Number of patients with new treatment emergent AEs since completing lead-in study
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
159 participants
Primary outcome timeframe
Week 12
Results posted on
2025-02-06
Participant Flow
Participant milestones
| Measure |
Placebo- TNX-102 SL 2.8 mg
These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg
These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg
These patients received 2x TNX-102 SL 2.8 mg sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
64
|
37
|
|
Overall Study
COMPLETED
|
47
|
49
|
32
|
|
Overall Study
NOT COMPLETED
|
11
|
15
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions
Baseline characteristics by cohort
| Measure |
Placebo- TNX-102 SL 2.8 mg
n=54 Participants
These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg
n=60 Participants
These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg
n=35 Participants
These patients received 2x TNX-102 SL 2.8 mg sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 7.00 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 8.22 • n=7 Participants
|
35.4 years
STANDARD_DEVIATION 9.27 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 8.11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
139 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
60 participants
n=7 Participants
|
35 participants
n=5 Participants
|
149 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Results are reported for the safety population, which includes all patients who received at least one dose of investigational product under this protocol.
Number of patients with new treatment emergent AEs since completing lead-in study
Outcome measures
| Measure |
Placebo- TNX-102 SL 2.8 mg
n=54 Participants
These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg
n=60 Participants
These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg
n=35 Participants
These patients received 2x TNX-102 SL 2.8 mg sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
|---|---|---|---|
|
Newly Treatment Emergent Adverse Events
|
37 Participants
|
20 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12Population: Only patients with data available at all timepoints were evaluated.
Changes in total CAPS-5 score from baseline in lead-in study and since baseline in this study. CAPS-5 score ranges from 0-80 with lower scores indicating less sever PTSD symptoms.
Outcome measures
| Measure |
Placebo- TNX-102 SL 2.8 mg
n=48 Participants
These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg
n=51 Participants
These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg
n=33 Participants
These patients received 2x TNX-102 SL 2.8 mg sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
|---|---|---|---|
|
Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5)
Change from P201 Baseline to P202 Week 12
|
-25.3 units on a scale
Standard Error 2.55
|
-25.6 units on a scale
Standard Error 2.59
|
-26.9 units on a scale
Standard Error 2.80
|
|
Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5)
Change from P202 Baseline to P202 Week 12
|
-4.9 units on a scale
Standard Error 1.80
|
-4.8 units on a scale
Standard Error 1.82
|
-3.7 units on a scale
Standard Error 2.01
|
SECONDARY outcome
Timeframe: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P201 Week 12Population: Any patients with missing values are assigned as not achieving 30% improvement.
≥30% decrease in Total CAPS-5 score from baseline in lead-in study and since baseline in this study. Lower scores on CAPS-5 indicate less severe PTSD symptoms.
Outcome measures
| Measure |
Placebo- TNX-102 SL 2.8 mg
n=54 Participants
These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg
n=60 Participants
These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg
n=35 Participants
These patients received 2x TNX-102 SL 2.8 mg sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
|---|---|---|---|
|
Response Rates a in Total CAPS-5 Score
Patients with ≥30% decrease in Total CAPS-5 score from P201 Day 1 to P202 Week 12
|
43 Participants
|
47 Participants
|
30 Participants
|
|
Response Rates a in Total CAPS-5 Score
Patients with ≥30% decrease in Total CAPS-5 score from P202 Day 1 to P202 Week 12
|
20 Participants
|
24 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12Population: Only patients with data available at all timepoints were evaluated.
Changes from baseline in lead-in study and since baseline in this study in item scores, including * intrusion symptoms (Criterion B) - Score ranges from 0 to 20. * CAPS-5 item 2. (B-2) (unpleasant dreams related to the trauma) - Score ranges from 0 to 4 * persistent avoidance (Criterion C) - Score ranges from 0 to 8 * negative cognitions and mood (Criterion D) - Score ranges from 0 to 28 * arousal and reactivity (Criterion E) - Score ranges from 0 to 24 Lower scores indicate less severe symptoms on all items
Outcome measures
| Measure |
Placebo- TNX-102 SL 2.8 mg
n=48 Participants
These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg
n=51 Participants
These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg
n=33 Participants
These patients received 2x TNX-102 SL 2.8 mg sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
|---|---|---|---|
|
CAPS-5 Cluster Score Items
Change from P201 Day 1 to P202 Week 12 in Criterion B
|
-7.7 units on a scale
Standard Error 0.82
|
-7.4 units on a scale
Standard Error 0.82
|
-7.7 units on a scale
Standard Error 0.91
|
|
CAPS-5 Cluster Score Items
Change from P202 Day 1 to P202 Week 12 in Criterion B
|
-1.9 units on a scale
Standard Error 0.66
|
-1.5 units on a scale
Standard Error 0.66
|
-1.4 units on a scale
Standard Error 0.74
|
|
CAPS-5 Cluster Score Items
Change from P201 Day 1 to P202 Week 12 in Item B-2
|
-1.3 units on a scale
Standard Error 0.23
|
-1.4 units on a scale
Standard Error 0.24
|
-1.4 units on a scale
Standard Error 0.26
|
|
CAPS-5 Cluster Score Items
Change from P202 Day 1 to P202 Week 12 in Item B-2
|
-0.3 units on a scale
Standard Error 0.20
|
-0.4 units on a scale
Standard Error 0.21
|
-0.2 units on a scale
Standard Error 0.23
|
|
CAPS-5 Cluster Score Items
Change from P201 Day 1 to P202 Week 12 in Criterion C
|
-3.1 units on a scale
Standard Error 0.45
|
-3.2 units on a scale
Standard Error 0.45
|
-3.1 units on a scale
Standard Error 0.50
|
|
CAPS-5 Cluster Score Items
Change from P202 Day 1 to P202 Week 12 in Criterion C
|
-0.4 units on a scale
Standard Error 0.38
|
-0.5 units on a scale
Standard Error 0.39
|
-0.5 units on a scale
Standard Error 0.42
|
|
CAPS-5 Cluster Score Items
Change from P201 Day 1 to P202 Week 12 in Criterion D
|
-7.6 units on a scale
Standard Error 1.10
|
-8.4 units on a scale
Standard Error 1.12
|
-9.1 units on a scale
Standard Error 1.22
|
|
CAPS-5 Cluster Score Items
Change from P202 Day 1 to P202 Week 12 in Criterion D
|
-1.1 units on a scale
Standard Error 0.85
|
-1.8 units on a scale
Standard Error 0.85
|
-1.4 units on a scale
Standard Error 0.95
|
|
CAPS-5 Cluster Score Items
Change from P201 Day 1 to P202 Week 12 in Criterion E
|
-6.8 units on a scale
Standard Error 0.83
|
-6.4 units on a scale
Standard Error 0.84
|
-7.1 units on a scale
Standard Error 0.91
|
|
CAPS-5 Cluster Score Items
Change from P202 Day 1 to P202 Week 12 in Criterion E
|
-1.4 units on a scale
Standard Error 0.62
|
-0.9 units on a scale
Standard Error 0.62
|
-0.8 units on a scale
Standard Error 0.69
|
SECONDARY outcome
Timeframe: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12Population: Only patients with data available at all timepoints were evaluated.
Changes from baseline in lead-in study and since baseline in this study in MADRS. Score ranges from 0 to 60. Lower scores indicate less severe depression symptoms.
Outcome measures
| Measure |
Placebo- TNX-102 SL 2.8 mg
n=48 Participants
These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg
n=51 Participants
These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg
n=33 Participants
These patients received 2x TNX-102 SL 2.8 mg sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
|---|---|---|---|
|
Montgomery-Asberg Depression Rating Scale
Change from P201 Day 1 to P202 Week 12
|
-8.1 units on a scale
Standard Error 1.53
|
-9.3 units on a scale
Standard Error 1.57
|
-9.9 units on a scale
Standard Error 1.66
|
|
Montgomery-Asberg Depression Rating Scale
Change from P202 Day 1 to P202 Week 12
|
0.1 units on a scale
Standard Error 1.28
|
-1.1 units on a scale
Standard Error 1.30
|
-2.1 units on a scale
Standard Error 1.40
|
SECONDARY outcome
Timeframe: P201 Day 1 (12 weeks prior to P202 Day 1), P202 Day 1, P202 Week 12Population: Only patients with data available at all timepoints were evaluated.
Changes from baseline in lead-in study and since baseline in this study in PROMIS scores. Raw scores are converted to T-scores with mean of 50 and standard deviation of 10 using published conversion tables based on the US population. * Fatigue T-score ranges from 33.1 to 77.8. Lower scores indicate less fatigue * Sleep Disturbance T-score ranges from 28.9 to 76.5. Lower scores indicate less sleep disturbance * Global Physical Health T-score ranges from 16.2 to 67.7. Lower scores indicate better physical health * Global Mental Health T-score ranges from 21.2 to 67.6. Lower scores indicate better mental health
Outcome measures
| Measure |
Placebo- TNX-102 SL 2.8 mg
n=48 Participants
These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg
n=51 Participants
These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg
n=32 Participants
These patients received 2x TNX-102 SL 2.8 mg sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
|---|---|---|---|
|
PROMIS (Patient -Reported Outcome Measurement Information System)
Change from P201 Day 1 to P202 Week 12 in PROMIS Fatigue T-scores
|
-5.6 T-score
Standard Error 2.05
|
-6.4 T-score
Standard Error 2.08
|
-8.0 T-score
Standard Error 2.26
|
|
PROMIS (Patient -Reported Outcome Measurement Information System)
Change from P201 Day 1 to P202 Week 12 in PROMIS Sleep Disturbance T-scores
|
-10.4 T-score
Standard Error 2.50
|
-12.2 T-score
Standard Error 2.58
|
-14.3 T-score
Standard Error 2.75
|
|
PROMIS (Patient -Reported Outcome Measurement Information System)
Change from P202 Day 1 to P202 Week 12 in PROMIS Sleep Disturbance T-scores
|
0.7 T-score
Standard Error 2.36
|
0.4 T-score
Standard Error 2.40
|
-3.1 T-score
Standard Error 2.60
|
|
PROMIS (Patient -Reported Outcome Measurement Information System)
Change from P202 Day 1 to P202 Week 12 in PROMIS Fatigue T-scores
|
0.9 T-score
Standard Error 1.78
|
1.1 T-score
Standard Error 1.79
|
-0.4 T-score
Standard Error 1.93
|
|
PROMIS (Patient -Reported Outcome Measurement Information System)
Change from P201 Day 1 to P202 Week 12 in PROMIS Global Mental Health T-scores
|
7.1 T-score
Standard Error 1.76
|
7.1 T-score
Standard Error 1.79
|
10.1 T-score
Standard Error 1.95
|
|
PROMIS (Patient -Reported Outcome Measurement Information System)
Change from P202 Day 1 to P202 Week 12 in PROMIS Global Mental Health T-scores
|
0.5 T-score
Standard Error 1.50
|
0.2 T-score
Standard Error 1.53
|
1.8 T-score
Standard Error 1.67
|
|
PROMIS (Patient -Reported Outcome Measurement Information System)
Change from P201 Day 1 to P202 Week 12 in PROMIS Global Physical Health T-scores
|
3.1 T-score
Standard Error 1.50
|
3.2 T-score
Standard Error 1.53
|
5.8 T-score
Standard Error 1.66
|
|
PROMIS (Patient -Reported Outcome Measurement Information System)
Change from P202 Day 1 to P202 Week 12 in PROMIS Global Physical Health T-scores
|
-0.7 T-score
Standard Error 1.18
|
-0.2 T-score
Standard Error 1.20
|
1.7 T-score
Standard Error 1.30
|
Adverse Events
Placebo- TNX-102 SL 2.8 mg
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo- TNX-102 SL 2.8 mg
n=54 participants at risk
These patients received 2x Placebo sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX 102 SL 2.8 mg - TNX-102 SL 2.8 mg
n=60 participants at risk
These patients received 1x TNX-102 SL 2.8 mg sublingual tablet and 1x Placebo sublingual tablet daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
TNX-102 SL 5.6 mg - TNX-102 SL 2.8 mg
n=35 participants at risk
These patients received 2x TNX-102 SL 2.8 mg sublingual tablets daily at bedtime during the lead-in study (TNX-CY-P201) and 1x TNX-102 SL 2.8 mg tablet daily at bedtime during this open-label study.
|
|---|---|---|---|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
40.7%
22/54 • 12 Weeks
All adverse events are reported for the Safety population, which includes only the patients who took at least 1 dose of study medication in this study.
|
5.0%
3/60 • 12 Weeks
All adverse events are reported for the Safety population, which includes only the patients who took at least 1 dose of study medication in this study.
|
5.7%
2/35 • 12 Weeks
All adverse events are reported for the Safety population, which includes only the patients who took at least 1 dose of study medication in this study.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
16.7%
9/54 • 12 Weeks
All adverse events are reported for the Safety population, which includes only the patients who took at least 1 dose of study medication in this study.
|
1.7%
1/60 • 12 Weeks
All adverse events are reported for the Safety population, which includes only the patients who took at least 1 dose of study medication in this study.
|
0.00%
0/35 • 12 Weeks
All adverse events are reported for the Safety population, which includes only the patients who took at least 1 dose of study medication in this study.
|
|
Nervous system disorders
Somnolence
|
3.7%
2/54 • 12 Weeks
All adverse events are reported for the Safety population, which includes only the patients who took at least 1 dose of study medication in this study.
|
5.0%
3/60 • 12 Weeks
All adverse events are reported for the Safety population, which includes only the patients who took at least 1 dose of study medication in this study.
|
2.9%
1/35 • 12 Weeks
All adverse events are reported for the Safety population, which includes only the patients who took at least 1 dose of study medication in this study.
|
|
Product Issues
Product Taste Abnormal
|
5.6%
3/54 • 12 Weeks
All adverse events are reported for the Safety population, which includes only the patients who took at least 1 dose of study medication in this study.
|
0.00%
0/60 • 12 Weeks
All adverse events are reported for the Safety population, which includes only the patients who took at least 1 dose of study medication in this study.
|
0.00%
0/35 • 12 Weeks
All adverse events are reported for the Safety population, which includes only the patients who took at least 1 dose of study medication in this study.
|
Additional Information
Gregory M. Sullivan, Chief Medical Officer
Tonix Pharmaceuticals
Phone: 862-904-0355
Email: [email protected]
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