Trial Outcomes & Findings for Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia (NCT NCT02829814)
NCT ID: NCT02829814
Last Updated: 2025-02-25
Results Overview
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) numeric response scale (NRS). A score of 0 indicates "no pain at all", and a score of 10 indicates "worst possible pain".
TERMINATED
PHASE3
51 participants
Day 1, Week 12
2025-02-25
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 0 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8 mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
24
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
27
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There are 2 patients in the placebo group for whom sex was not recorded.
Baseline characteristics by cohort
| Measure |
Placebo SL Tablet
n=27 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 0 for 12 weeks.
|
TNX-102 SL Tablet, 2.8 mg
n=24 Participants
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 12 weeks
TNX-102 SL Tablet, 2.8 mg: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 10.10 • n=27 Participants
|
52.1 years
STANDARD_DEVIATION 7.45 • n=24 Participants
|
51.7 years
STANDARD_DEVIATION 8.87 • n=51 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=25 Participants • There are 2 patients in the placebo group for whom sex was not recorded.
|
23 Participants
n=24 Participants • There are 2 patients in the placebo group for whom sex was not recorded.
|
47 Participants
n=49 Participants • There are 2 patients in the placebo group for whom sex was not recorded.
|
|
Sex: Female, Male
Male
|
1 Participants
n=25 Participants • There are 2 patients in the placebo group for whom sex was not recorded.
|
1 Participants
n=24 Participants • There are 2 patients in the placebo group for whom sex was not recorded.
|
2 Participants
n=49 Participants • There are 2 patients in the placebo group for whom sex was not recorded.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=27 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=27 Participants
|
22 Participants
n=24 Participants
|
44 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=27 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=27 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=27 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=27 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=27 Participants
|
22 Participants
n=24 Participants
|
41 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=27 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=27 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=51 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=27 Participants
|
24 participants
n=24 Participants
|
51 participants
n=51 Participants
|
PRIMARY outcome
Timeframe: Day 1, Week 12Population: This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) numeric response scale (NRS). A score of 0 indicates "no pain at all", and a score of 10 indicates "worst possible pain".
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.
Proportion of patients with a PGIC rating of "very much improved" or "much improved" at Week 12.The PGIC is a 7-point scale (1=very much improved; 7=very much worse) that assesses the patient's perception of the overall change in his/her fibromyalgia symptoms since entering the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Week 12Population: This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.
Change from Baseline in the FIQR symptoms domain score at Week 12. The FIQ-R symptom domain is composed of 10 questions. All questions are based on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." Symptom domain scores range from 0-100, with higher scores reflecting worse status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Week 12Population: This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.
Change from Baseline in the FIQR function domain score at Week 12. The FIQ-R functional domain score is composed of 9 questions which are rated on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." FIQ-R functional domain scores can range from 0-90, with higher scores reflecting worsening status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.
Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12. Daily sleep quality was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse sleep.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, Week 12Population: This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.
Change from Baseline in the PROMIS score for sleep disturbance at Week 12. The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.
Change from Baseline in the PROMIS score for fatigue at Week 12. The Patient-Reported Outcome Measurement Information System (PROMIS) fatigue instrument consists of 8 items in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week -1 (Day -7 to Day -1), Week 12Population: This study was stopped for business reasons prior to any patients completing the study. Therefore, no efficacy analyses were performed.
Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Weekly averages were calculated based on the reported daily scores.
Outcome measures
Outcome data not reported
Adverse Events
Placebo SL Tablet
TNX-102 SL Tablet, 2.8 mg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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