Trial Outcomes & Findings for A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia (NCT NCT02436096)
NCT ID: NCT02436096
Last Updated: 2025-02-07
Results Overview
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement (responder criteria) from baseline to Week 12 in the weekly mean of the daily self-reported 24-hour recall average pain intensity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
519 participants
Primary outcome timeframe
Day 1, Week 12
Results posted on
2025-02-07
Participant Flow
Participant milestones
| Measure |
Placebo SL Tablet
1 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 each day at bedtime starting on Day 1 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
257
|
262
|
|
Overall Study
COMPLETED
|
222
|
203
|
|
Overall Study
NOT COMPLETED
|
35
|
59
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia
Baseline characteristics by cohort
| Measure |
Placebo SL Tablet
n=257 Participants
1 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 each day at bedtime starting on Day 1 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
n=262 Participants
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
|
Total
n=519 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 11.16 • n=7 Participants
|
47.8 years
STANDARD_DEVIATION 11.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
247 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
499 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
236 Participants
n=5 Participants
|
231 Participants
n=7 Participants
|
467 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
221 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
463 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
257 participants
n=5 Participants
|
262 participants
n=7 Participants
|
519 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, Week 12Population: Results are reported for the ITT population which includes all patients who were randomized.
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement (responder criteria) from baseline to Week 12 in the weekly mean of the daily self-reported 24-hour recall average pain intensity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Placebo SL Tablet
n=257 Participants
1 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 each day at bedtime starting on Day 1 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
n=262 Participants
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
|
|---|---|---|
|
Proportion of Patients With ≥30% Pain Improvement
|
58 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Results are reported for the ITT population which includes all patients who were randomized.
Proportion of patients with a PGIC rating of 1 ("very much improved") or 2 ("much improved") at Week 12. 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 the highest level of worsening.
Outcome measures
| Measure |
Placebo SL Tablet
n=257 Participants
1 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 each day at bedtime starting on Day 1 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
n=262 Participants
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
|
|---|---|---|
|
Patient's Global Impression of Change (PGIC)
|
42 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: Day 1, Week 12Population: Results are reported for the ITT population which includes all patients who were randomized.
The FIQR is a validated questionnaire. Scores on the symptoms domain range from 0 to 100 where a higher score means worse outcome.
Outcome measures
| Measure |
Placebo SL Tablet
n=257 Participants
1 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 each day at bedtime starting on Day 1 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
n=262 Participants
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score
|
-8.2 units on a scale
Standard Error 1.13
|
-14.1 units on a scale
Standard Error 1.14
|
SECONDARY outcome
Timeframe: Day 1, Week 12Population: Results are reported for the ITT population which includes all patients who were randomized.
The FIQR is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome.
Outcome measures
| Measure |
Placebo SL Tablet
n=257 Participants
1 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 each day at bedtime starting on Day 1 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
n=262 Participants
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
|
|---|---|---|
|
Change From Baseline to Week 12 in the FIQR Function Domain Score
|
-4.4 units on a scale
Standard Error 1.15
|
-10.3 units on a scale
Standard Error 1.16
|
SECONDARY outcome
Timeframe: Day 1, Week 12Population: Results are reported for the ITT population which includes all patients who were randomized.
Change from baseline in the PROMIS score for sleep disturbance at Week 12. 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. Lower T-scores indicate less sleep disturbance.
Outcome measures
| Measure |
Placebo SL Tablet
n=257 Participants
1 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 each day at bedtime starting on Day 1 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
n=262 Participants
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
|
|---|---|---|
|
Patient Reported Outcomes Measurement System (PROMIS) Sleep Disturbance
|
-4.7 T-score
Standard Error .53
|
-8.0 T-score
Standard Error .54
|
SECONDARY outcome
Timeframe: Baseline (Day -7 to Day -1), Week 12Population: Results are reported for the ITT population which includes all patients who were randomized.
Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12. 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 |
Placebo SL Tablet
n=257 Participants
1 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 each day at bedtime starting on Day 1 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
n=262 Participants
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
|
|---|---|---|
|
Weekly Average of Daily Sleep Quality Diary
|
-1.0 units on a scale
Standard Error 0.11
|
-1.8 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Day 1, Week 12Population: Results are reported for the ITT population which includes all patients who were randomized.
Change from Baseline in the PROMIS score for fatigue at Week 12. 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. Lower T-scores indicate less fatigue.
Outcome measures
| Measure |
Placebo SL Tablet
n=257 Participants
1 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 each day at bedtime starting on Day 1 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
n=262 Participants
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
|
|---|---|---|
|
Patient Reported Outcomes Measurement System (PROMIS) Fatigue
|
-4.2 T-score
Standard Error .47
|
-6.4 T-score
Standard Error .47
|
SECONDARY outcome
Timeframe: Baseline (Day -7 to Day -1), Week 12Population: Results are reported for the ITT population which includes all patients who were randomized.
Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Outcome measures
| Measure |
Placebo SL Tablet
n=257 Participants
1 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 each day at bedtime starting on Day 1 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
n=262 Participants
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
|
|---|---|---|
|
Weekly Average of Daily Pain Diary
|
-1.0 units on a scale
Standard Error 0.11
|
-1.5 units on a scale
Standard Error 0.11
|
Adverse Events
Placebo SL Tablet
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
TNX-102 SL Tablet, 2.8 mg
Serious events: 3 serious events
Other events: 132 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo SL Tablet
n=256 participants at risk
1 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 each day at bedtime starting on Day 1 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
n=262 participants at risk
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
|
|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/256 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
0.38%
1/262 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/256 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
0.38%
1/262 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/256 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
0.38%
1/262 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
|
Nervous system disorders
Dizziness
|
0.39%
1/256 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
0.00%
0/262 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
|
Nervous system disorders
Presyncope
|
0.39%
1/256 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
0.00%
0/262 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.39%
1/256 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
0.00%
0/262 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
|
General disorders
Non-cardiac Chest Pain
|
0.39%
1/256 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
0.00%
0/262 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.39%
1/256 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
0.00%
0/262 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
Other adverse events
| Measure |
Placebo SL Tablet
n=256 participants at risk
1 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 each day at bedtime starting on Day 1 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
n=262 participants at risk
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.78%
2/256 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
40.1%
105/262 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
|
Gastrointestinal disorders
Glossodynia
|
1.6%
4/256 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
9.2%
24/262 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
1.2%
3/256 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
7.6%
20/262 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
|
Product Issues
Product Taste Abnormal
|
0.78%
2/256 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
6.1%
16/262 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
|
General disorders
Fatigue
|
2.3%
6/256 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
5.7%
15/262 • 12 Weeks
All data is reported for the Safety population, which is defined as all patients who were issued investigational product.
|
Additional Information
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