Phase 3
Completed N=514
A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Source: ClinicalTrials.gov NCT04508621 ↗Enrolled (actual)
514
Serious AEs
1.2%
Results posted
Dec 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. — -1.6; -1.3 score on a scale — p=0.115
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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. |
-1.6; -1.3 | 0.115 |
| SECONDARY Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved" |
76; 56 | 0.038 sig |
| SECONDARY Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score. |
-15.3; -12.0 | 0.030 sig |
| SECONDARY Change From Baseline to Week 14 in the FIQ-R Function Domain Score |
-8.8; -8.4 | 0.797 |
| SECONDARY Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance |
-7.4; -5.1 | 0.004 sig |
| SECONDARY Change From Baseline to Week 14 in the PROMIS Score for Fatigue |
-6.6; -5.4 | 0.101 |
| SECONDARY Change From Baseline to Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality |
-1.5; -1.3 | 0.094 |
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 defined range.
Exclusion Criteria
- History of or evidence for a diagnosis of borderline personality disorder (BPD).
Data sourced from ClinicalTrials.gov (NCT04508621). 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.