Trial Outcomes & Findings for A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia (NCT NCT04172831)
NCT ID: NCT04172831
Last Updated: 2022-08-08
Results Overview
Patients provide a daily numeric assessment of their average pain (24-hour recall), via an electronic diary, using an 11-point NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
503 participants
Primary outcome timeframe
14 weeks
Results posted on
2022-08-08
Participant Flow
Participant milestones
| Measure |
TNX-102 SL Tablets, 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
|
248
|
255
|
|
Overall Study
COMPLETED
|
204
|
213
|
|
Overall Study
NOT COMPLETED
|
44
|
42
|
Reasons for withdrawal
| Measure |
TNX-102 SL Tablets, 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
|
21
|
9
|
|
Overall Study
Lack of Efficacy
|
2
|
8
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
11
|
|
Overall Study
Lost to Follow-up
|
4
|
9
|
|
Overall Study
COVID-19 related crisis
|
3
|
3
|
|
Overall Study
Subject non-compliance
|
1
|
1
|
|
Overall Study
Family emergency
|
1
|
0
|
Baseline Characteristics
A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Baseline characteristics by cohort
| Measure |
TNX-102 SL Tablets, 5.6 mg
n=248 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=255 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=503 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 9.40 • n=113 Participants
|
49.3 years
STANDARD_DEVIATION 10.16 • n=163 Participants
|
49.6 years
STANDARD_DEVIATION 9.79 • n=160 Participants
|
|
Sex: Female, Male
Female
|
232 Participants
n=113 Participants
|
247 Participants
n=163 Participants
|
479 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=113 Participants
|
8 Participants
n=163 Participants
|
24 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=113 Participants
|
5 Participants
n=163 Participants
|
7 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=113 Participants
|
20 Participants
n=163 Participants
|
39 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
222 Participants
n=113 Participants
|
216 Participants
n=163 Participants
|
438 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=113 Participants
|
9 Participants
n=163 Participants
|
12 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
248 participants
n=113 Participants
|
255 participants
n=163 Participants
|
503 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: 14 weeksPopulation: Intent to Treat Population (all patient who were randomized). Multiple imputation for missing data.
Patients provide a daily numeric assessment of their average pain (24-hour recall), via an electronic diary, using an 11-point NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
TNX-102 SL Tablets, 5.6 mg
n=248 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=255 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 Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.
|
-1.9 score on a scale
Interval -2.1 to -1.7
|
-1.5 score on a scale
Interval -1.7 to -1.3
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Intent to Treat population (all patient who were randomized). Patients with missing data as non-responders.
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 Tablets, 5.6 mg
n=248 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=255 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.
|
|---|---|---|
|
Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved"
|
93 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Intent to Treat Population (all patients who were randomized). Multiple imputation for missing data.
The FIQ-R is a validated questionnaire. Scores on the symptoms domain range from 0 to 100 where a higher score means worse outcome.
Outcome measures
| Measure |
TNX-102 SL Tablets, 5.6 mg
n=248 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=255 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 Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score
|
-18.4 score on a scale
Interval -20.8 to -16.0
|
-14.0 score on a scale
Interval -16.4 to -11.7
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Intent to Treat Population (all patients who were randomized). Multiple imputation for missing data.
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 Tablets, 5.6 mg
n=248 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=255 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 Week 14 in the FIQR Function Domain Score
|
-13.6 score on a scale
Interval -16.1 to -11.2
|
-9.3 score on a scale
Interval -11.7 to -6.8
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Intent to Treat population (all patients who were randomized). Multiple imputation for missing data.
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.
Outcome measures
| Measure |
TNX-102 SL Tablets, 5.6 mg
n=248 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=255 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 Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance
|
-9.5 score on a scale
Interval -10.7 to -8.2
|
-6.5 score on a scale
Interval -7.7 to -5.4
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Intent to Treat population (all patients who were randomized). Multiple imputation for missing data.
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.
Outcome measures
| Measure |
TNX-102 SL Tablets, 5.6 mg
n=248 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=255 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 Week 14 in the PROMIS Score for Fatigue
|
-8.0 score on a scale
Interval -9.1 to -6.9
|
-6.2 score on a scale
Interval -7.4 to -5.0
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Intent to Treat population (all patients who were randomized). Multiple imputation for missing data.
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 Tablets, 5.6 mg
n=248 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=255 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 Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality
|
-2.0 score on a scale
Interval -2.3 to -1.8
|
-1.5 score on a scale
Interval -1.7 to -1.2
|
Adverse Events
TNX-102 SL Tablets, 5.6 mg
Serious events: 2 serious events
Other events: 70 other events
Deaths: 0 deaths
Placebo SL Tablet
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TNX-102 SL Tablets, 5.6 mg
n=248 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=255 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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.40%
1/248 • 14 weeks
|
0.00%
0/255 • 14 weeks
|
|
Infections and infestations
Pneumonia
|
0.40%
1/248 • 14 weeks
|
0.00%
0/255 • 14 weeks
|
|
Gastrointestinal disorders
Coeliac artery compression syndrome
|
0.00%
0/248 • 14 weeks
|
0.39%
1/255 • 14 weeks
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/248 • 14 weeks
|
0.39%
1/255 • 14 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/248 • 14 weeks
|
0.39%
1/255 • 14 weeks
|
|
Vascular disorders
Hypotention
|
0.00%
0/248 • 14 weeks
|
0.39%
1/255 • 14 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/248 • 14 weeks
|
0.39%
1/255 • 14 weeks
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.40%
1/248 • 14 weeks
|
0.00%
0/255 • 14 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/248 • 14 weeks
|
0.39%
1/255 • 14 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/248 • 14 weeks
|
0.39%
1/255 • 14 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/248 • 14 weeks
|
0.39%
1/255 • 14 weeks
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/248 • 14 weeks
|
0.39%
1/255 • 14 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/248 • 14 weeks
|
0.39%
1/255 • 14 weeks
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/248 • 14 weeks
|
0.39%
1/255 • 14 weeks
|
Other adverse events
| Measure |
TNX-102 SL Tablets, 5.6 mg
n=248 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=255 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
|
17.3%
43/248 • 14 weeks
|
0.39%
1/255 • 14 weeks
|
|
Gastrointestinal disorders
Paraesthesia oral
|
5.6%
14/248 • 14 weeks
|
0.39%
1/255 • 14 weeks
|
|
Nervous system disorders
Dysguesia
|
5.2%
13/248 • 14 weeks
|
0.39%
1/255 • 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