Phase 3
N=457
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT05273749 ↗Enrolled (actual)
457
Serious AEs
1.1%
Results posted
Dec 2024
Primary outcome: Primary: Change From Baseline to the Week 14 Endpoint in the Diary NRS Weekly Average of Daily Self Reported Average Pain Severity Scores. — -1.8; -1.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TNX-102 SL Tablet, 5.6 mg (Drug); Placebo SL Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tonix Pharmaceuticals, Inc.
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to the Week 14 Endpoint in the Diary NRS Weekly Average of Daily Self Reported Average Pain Severity Scores. |
-1.8; -1.2 | — |
| SECONDARY Proportion of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved" at the Week 14 Endpoint |
66; 34 | — |
| SECONDARY Change From Baseline in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score at the Week 14 Endpoint |
-16.0; -8.4 | — |
| SECONDARY Change From Baseline in the FIQ-R Function Domain Score at the Week 14 Endpoint |
-12.2; -6.8 | — |
| SECONDARY Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance at the Week 14 Endpoint |
-8.4; -4.2 | — |
| SECONDARY Change From Baseline in the PROMIS Score for Fatigue at the Week 14 Endpoint |
-7.2; -4.2 | — |
| SECONDARY Change From Baseline in the Weekly Average of the Daily Diary Assessment of Sleep Quality at the Week 14 Endpoint |
-1.8; -1.2 | — |
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.
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)
Exclusion Criteria
- The patient has been diagnosed with infectious or inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attacks within past 2 years is exclusionary), or meets criteria for other type of systemic autoimmune disease.
Data sourced from ClinicalTrials.gov (NCT05273749). 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.