Trial Outcomes & Findings for A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection (NCT NCT05472090)
NCT ID: NCT05472090
Last Updated: 2024-11-26
Results Overview
Change from Baseline in the diary Numeric Rating Scale (NRS) weekly average of daily self-reported worst Long COVID pain intensity scores at the Week 14 endpoint. Scores range from 0 to 10 where a higher score means worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
Week 14
Results posted on
2024-11-26
Participant Flow
Participant milestones
| Measure |
TNX-102 SL Tablet, 5.6 mg
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
TNX-102 SL Tablet, 5.6 mg
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection
Baseline characteristics by cohort
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=32 Participants
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=31 Participants
1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 8.80 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 10.01 • n=7 Participants
|
50.0 years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
|
29.78 kg/m^2
STANDARD_DEVIATION 4.067 • n=5 Participants
|
29.49 kg/m^2
STANDARD_DEVIATION 4.439 • n=7 Participants
|
29.64 kg/m^2
STANDARD_DEVIATION 4.222 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 14Population: Intention-to-treat (ITT) population defined as all patients who were randomized and had at least one post-baseline daily diary entry.
Change from Baseline in the diary Numeric Rating Scale (NRS) weekly average of daily self-reported worst Long COVID pain intensity scores at the Week 14 endpoint. Scores range from 0 to 10 where a higher score means worse outcome.
Outcome measures
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=32 Participants
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=31 Participants
1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
Daily Diary Pain NRS
|
-2.2 units on a scale
Standard Error 0.34
|
-2.0 units on a scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Week 14Population: Intention-to-treat (ITT) population defined as all patients who were randomized and had at least one post-baseline daily diary entry.
Mean change from baseline in the weekly average of the daily diary numeric rating scale (NRS) assessment of sleep quality at the Week 14 endpoint. Scores range from 0 to 10 where a higher score means worse outcome.
Outcome measures
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=32 Participants
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=31 Participants
1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
Daily Diary Sleep Quality NRS
|
-2.1 units on a scale
Standard Error 0.38
|
-1.6 units on a scale
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Week 14Population: Intention-to-treat (ITT) population defined as all patients who were randomized and had at least one post-baseline daily diary entry.
Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue at the Week 14 endpoint. Subjects are asked to reflect on their fatigue symptoms in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.
Outcome measures
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=32 Participants
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=31 Participants
1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
PROMIS Fatigue -Short Form 8a
|
-8.0 T-score
Standard Error 1.65
|
-3.2 T-score
Standard Error 1.68
|
SECONDARY outcome
Timeframe: Week 14Population: Intention-to-treat (ITT) population defined as all patients who were randomized and had at least one post-baseline daily diary entry.
Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for cognitive function at the Week 14 endpoint. Subjects are asked to reflect on their cognitive function and abilities in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.
Outcome measures
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=32 Participants
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=31 Participants
1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
PROMIS Cognitive Function - Abilities-Short Form 8a
|
5.4 T-score
Standard Error 1.55
|
3.5 T-score
Standard Error 1.55
|
Adverse Events
TNX-102 SL Tablet, 5.6 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo SL Tablet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=32 participants at risk
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.
TNX-102 SL: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=31 participants at risk
1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Placebo SL Tablet: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
18.8%
6/32 • Patients were monitored for AEs throughout the study. The total duration of the study, including screening and follow up, was as long as 25 weeks.
|
0.00%
0/31 • Patients were monitored for AEs throughout the study. The total duration of the study, including screening and follow up, was as long as 25 weeks.
|
|
Gastrointestinal disorders
Glossodynia
|
6.2%
2/32 • Patients were monitored for AEs throughout the study. The total duration of the study, including screening and follow up, was as long as 25 weeks.
|
0.00%
0/31 • Patients were monitored for AEs throughout the study. The total duration of the study, including screening and follow up, was as long as 25 weeks.
|
|
Gastrointestinal disorders
Oral Pain
|
6.2%
2/32 • Patients were monitored for AEs throughout the study. The total duration of the study, including screening and follow up, was as long as 25 weeks.
|
0.00%
0/31 • Patients were monitored for AEs throughout the study. The total duration of the study, including screening and follow up, was as long as 25 weeks.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
6.2%
2/32 • Patients were monitored for AEs throughout the study. The total duration of the study, including screening and follow up, was as long as 25 weeks.
|
0.00%
0/31 • Patients were monitored for AEs throughout the study. The total duration of the study, including screening and follow up, was as long as 25 weeks.
|
|
General disorders
Influenza like illness
|
0.00%
0/32 • Patients were monitored for AEs throughout the study. The total duration of the study, including screening and follow up, was as long as 25 weeks.
|
6.5%
2/31 • Patients were monitored for AEs throughout the study. The total duration of the study, including screening and follow up, was as long as 25 weeks.
|
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