Trial Outcomes & Findings for A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia (NCT NCT04508621)
NCT ID: NCT04508621
Last Updated: 2023-12-18
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
514 participants
Primary outcome timeframe
14 weeks
Results posted on
2023-12-18
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 patient 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
256
|
258
|
|
Overall Study
COMPLETED
|
189
|
210
|
|
Overall Study
NOT COMPLETED
|
67
|
48
|
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 patient 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
39
|
16
|
|
Overall Study
Lack of Efficacy
|
2
|
8
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
14
|
|
Overall Study
Lost to Follow-up
|
12
|
9
|
|
Overall Study
COVID-19 related crisis
|
3
|
0
|
|
Overall Study
Subject non-compliance
|
1
|
0
|
Baseline Characteristics
A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Baseline characteristics by cohort
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=256 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=258 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
Total
n=514 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 10.55 • n=5 Participants
|
48.5 years
STANDARD_DEVIATION 10.60 • n=7 Participants
|
48.7 years
STANDARD_DEVIATION 10.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
242 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
487 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
226 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
449 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
256 participants
n=5 Participants
|
258 participants
n=7 Participants
|
514 participants
n=5 Participants
|
PRIMARY 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 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 Tablet, 5.6 mg
n=256 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=258 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 patient 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.
|
-1.6 score on a scale
Interval -1.8 to -1.3
|
-1.3 score on a scale
Interval -1.5 to -1.1
|
SECONDARY outcome
Timeframe: 14 weeksPopulation: Intent to Treat population (all patients 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 Tablet, 5.6 mg
n=256 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=258 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 patient 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"
|
76 Participants
|
56 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 Tablet, 5.6 mg
n=256 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=258 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score.
|
-15.3 score on a scale
Interval -17.6 to -13.1
|
-12.0 score on a scale
Interval -14.2 to -9.8
|
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. Score 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=256 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=258 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
Change From Baseline to Week 14 in the FIQ-R Function Domain Score
|
-8.8 score on a scale
Interval -10.9 to -6.7
|
-8.4 score on a scale
Interval -10.5 to -6.4
|
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 Tablet, 5.6 mg
n=256 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=258 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 patient 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
|
-7.4 score on a scale
Interval -8.6 to -6.2
|
-5.1 score on a scale
Interval -6.2 to -4.0
|
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 consist 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 Tablet, 5.6 mg
n=256 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=258 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
Change From Baseline to Week 14 in the PROMIS Score for Fatigue
|
-6.6 score on a scale
Interval -7.7 to -5.5
|
-5.4 score on a scale
Interval -6.4 to -4.3
|
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 Tablet, 5.6 mg
n=256 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=258 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 patient 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
|
-1.5 score on a scale
Interval -1.7 to -1.3
|
-1.3 score on a scale
Interval -1.5 to -1.0
|
Adverse Events
TNX-102 SL Tablet, 5.6 mg
Serious events: 6 serious events
Other events: 80 other events
Deaths: 0 deaths
Placebo SL Tablet
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=256 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=258 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.39%
1/256 • 14 weeks
|
0.00%
0/258 • 14 weeks
|
|
Infections and infestations
Localized infection
|
0.39%
1/256 • 14 weeks
|
0.00%
0/258 • 14 weeks
|
|
Infections and infestations
Pneumonia
|
0.39%
1/256 • 14 weeks
|
0.00%
0/258 • 14 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.39%
1/256 • 14 weeks
|
0.00%
0/258 • 14 weeks
|
|
Hepatobiliary disorders
Bile duct stone
|
0.39%
1/256 • 14 weeks
|
0.00%
0/258 • 14 weeks
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.39%
1/256 • 14 weeks
|
0.00%
0/258 • 14 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.39%
1/256 • 14 weeks
|
0.00%
0/258 • 14 weeks
|
Other adverse events
| Measure |
TNX-102 SL Tablet, 5.6 mg
n=256 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
Placebo SL Tablet
n=258 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 patient will have the dose increased to 2 tablets for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
28.1%
72/256 • 14 weeks
|
0.78%
2/258 • 14 weeks
|
|
Gastrointestinal disorders
Oral discomfort
|
9.0%
23/256 • 14 weeks
|
0.78%
2/258 • 14 weeks
|
|
Gastrointestinal disorders
Tongue discomfort
|
6.2%
16/256 • 14 weeks
|
0.78%
2/258 • 14 weeks
|
|
Product Issues
Product taste abnormal
|
10.2%
26/256 • 14 weeks
|
0.78%
2/258 • 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