Phase 3
Completed N=503
A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Fibromyalgia
Source: ClinicalTrials.gov NCT04172831 ↗
Enrolled (actual)
503
Serious AEs
1.4%
Results posted
Aug 2022
Primary outcomePrimary: Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores. — -1.9; -1.5 score on a scale — p=0.010
◆ Published Evidence
Established
43citations · ~14 / year
Efficacy and Safety of Sublingual Cyclobenzaprine for the Treatment of Fibromyalgia: Results From a Randomized, Double-Blind, Placebo-Controlled Trial.
Summary
This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.
Linked Publications
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Efficacy and Safety of Sublingual Cyclobenzaprine for the Treatment of Fibromyalgia: Results From a Randomized, Double-Blind, Placebo-Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores. |
-1.9; -1.5 | 0.010 sig |
| SECONDARY Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved" |
93; 75 | 0.058 |
| SECONDARY Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score |
-18.4; -14.0 | 0.007 sig |
| SECONDARY Change From Baseline to Week 14 in the FIQR Function Domain Score |
-13.6; -9.3 | 0.009 sig |
| SECONDARY Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance |
-9.5; -6.5 | <0.001 sig |
| SECONDARY Change From Baseline to Week 14 in the PROMIS Score for Fatigue |
-8.0; -6.2 | 0.018 sig |
| SECONDARY Change From Baseline to Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality |
-2.0; -1.5 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- The patient is male or female 18 to 65 years of age, inclusive.
- The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
- The in-clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol specified range.
Exclusion Criteria
- History of or evidence for a diagnosis of borderline personality disorder (BPD).
Data sourced from ClinicalTrials.gov (NCT04172831) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.