Trial Outcomes & Findings for A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia (NCT NCT05273749)
NCT ID: NCT05273749
Last Updated: 2025-01-22
Results Overview
Change from Baseline to the Week 14 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
457 participants
Primary outcome timeframe
Baseline (Day -7 to Day -1), Week 14
Results posted on
2025-01-22
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 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.
|
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
|
231
|
226
|
|
Overall Study
COMPLETED
|
187
|
179
|
|
Overall Study
NOT COMPLETED
|
44
|
47
|
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 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.
|
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
|
14
|
8
|
|
Overall Study
Lack of Efficacy
|
2
|
8
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
14
|
16
|
|
Overall Study
Lost to Follow-up
|
10
|
10
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Non-Compliance
|
3
|
2
|
|
Overall Study
Patient should not have been randomized due to ongoing unstable medical condition
|
0
|
1
|
Baseline Characteristics
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia
Baseline characteristics by cohort
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=231 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=226 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=457 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 10.45 • n=99 Participants
|
49.5 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
49.4 years
STANDARD_DEVIATION 10.88 • n=206 Participants
|
|
Sex: Female, Male
Female
|
224 Participants
n=99 Participants
|
212 Participants
n=107 Participants
|
436 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
195 Participants
n=99 Participants
|
190 Participants
n=107 Participants
|
385 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
194 Participants
n=99 Participants
|
192 Participants
n=107 Participants
|
386 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day -7 to Day -1), Week 14Population: Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment.
Change from Baseline to the Week 14 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome.
Outcome measures
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=231 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=225 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.
|
|---|---|---|
|
Change From Baseline to the Week 14 Endpoint in the Diary NRS Weekly Average of Daily Self Reported Average Pain Severity Scores.
|
-1.8 score on a scale
Interval -2.0 to -1.6
|
-1.2 score on a scale
Interval -1.4 to -0.9
|
SECONDARY outcome
Timeframe: Week 14Population: Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment.
The PGIC is a fibromyalgia specific validated instrument on a scale of 1 to 7, where a score of 1 indicates the highest level of improvement and a score of 7 indicates a much worse outcome.
Outcome measures
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=231 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=225 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.
|
|---|---|---|
|
Proportion of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved" at the Week 14 Endpoint
|
66 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Day 1, Week 14Population: Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment.
Change from Baseline in the FIQ-R Symptoms domain score at the Week 14 endpoint. Scores on the symptoms domain range from 0 to 90 where a higher score means worse outcome.
Outcome measures
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=231 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=225 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.
|
|---|---|---|
|
Change From Baseline in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score at the Week 14 Endpoint
|
-16.0 score on a scale
Interval -18.3 to -13.7
|
-8.4 score on a scale
Interval -10.7 to -6.1
|
SECONDARY outcome
Timeframe: Day 1, Week 14Population: Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment.
The FIQ-R is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome.
Outcome measures
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=231 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=225 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.
|
|---|---|---|
|
Change From Baseline in the FIQ-R Function Domain Score at the Week 14 Endpoint
|
-12.2 score on a scale
Interval -14.5 to -9.9
|
-6.8 score on a scale
Interval -9.2 to -4.4
|
SECONDARY outcome
Timeframe: Day 1, Week 14Population: Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment.
The PROMIS Sleep disturbance short form 8a consists of 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=231 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=225 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.
|
|---|---|---|
|
Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance at the Week 14 Endpoint
|
-8.4 T-score
Interval -9.6 to -7.3
|
-4.2 T-score
Interval -5.3 to -3.1
|
SECONDARY outcome
Timeframe: Day 1, Week 14Population: Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment.
The PROMIS fatigue short form 8a consists of 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=231 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=225 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.
|
|---|---|---|
|
Change From Baseline in the PROMIS Score for Fatigue at the Week 14 Endpoint
|
-7.2 T-score
Interval -8.3 to -6.1
|
-4.2 T-score
Interval -5.3 to -3.1
|
SECONDARY outcome
Timeframe: Baseline (Day -7 to Day -1), Week 14Population: Intention-To-Treat (ITT) population: all patients who were randomized. This is the primary population for efficacy analyses, and patients will be analyzed based on their randomized treatment.
Patients provide a daily numeric assessment of their sleep quality for the previous night, via an electronic diary, using an 11-point NRS. Scores range from 0 (best possible sleep) to 10 (worst possible sleep).
Outcome measures
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=231 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=225 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.
|
|---|---|---|
|
Change From Baseline in the Weekly Average of the Daily Diary Assessment of Sleep Quality at the Week 14 Endpoint
|
-1.8 score on a scale
Interval -2.0 to -1.5
|
-1.2 score on a scale
Interval -1.4 to -1.0
|
Adverse Events
TNX-102 SL Tablet, 5.6 mg
Serious events: 2 serious events
Other events: 78 other events
Deaths: 0 deaths
Placebo SL Tablet
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=231 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=226 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
Pancreatitis acute
|
0.43%
1/231 • 14 Weeks
|
0.00%
0/226 • 14 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.43%
1/231 • 14 Weeks
|
0.00%
0/226 • 14 Weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/231 • 14 Weeks
|
0.44%
1/226 • 14 Weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/231 • 14 Weeks
|
0.44%
1/226 • 14 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/231 • 14 Weeks
|
0.44%
1/226 • 14 Weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/231 • 14 Weeks
|
0.44%
1/226 • 14 Weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/231 • 14 Weeks
|
0.44%
1/226 • 14 Weeks
|
Other adverse events
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=231 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=226 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
|
23.8%
55/231 • 14 Weeks
|
0.44%
1/226 • 14 Weeks
|
|
Gastrointestinal disorders
Paraesthesia oral
|
6.9%
16/231 • 14 Weeks
|
0.88%
2/226 • 14 Weeks
|
|
Gastrointestinal disorders
Tongue discomfort
|
6.9%
16/231 • 14 Weeks
|
0.00%
0/226 • 14 Weeks
|
|
Product Issues
Product taste abnormal
|
11.7%
27/231 • 14 Weeks
|
0.88%
2/226 • 14 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