A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

Study Overview
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Brief Summary
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The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology. The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.

Official Title
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A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia

Conditions
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Neuromuscular Diseases, Rheumatic Diseases, Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Musculoskeletal Diseases, Nervous System Diseases

Intervention / Treatment
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* Drug: TNX-102 SL Tablet, 2.8mg
* Drug: Placebo SL Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Primary Fibromyalgia (2010 ACR criteria) Male or female 18-75 years old For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressant therapy Willing and able to withdraw specific therapies (ask PI) Medically acceptable form of contraception (female only) Signed informed consent Exclusion Criteria: Arthritis, lupus and other systemic auto-immune diseases Regional or persistent pain that could interfere with assessment of fibromyalgia pain Bipolar and psychotic disorders Increased risk of suicide Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities. Unability to wash-out specific medications (ask PI) Known hypersensitivity to cyclobenzaprine Others: seizure disorders, severe/untreated sleep apnea, BMI>40

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNX-102 SL Tablet, 2.8 mg<br>1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks | Drug: TNX-102 SL Tablet, 2.8mg<br>* Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.<br>* Other names: Low dose cyclobenzaprine sublingual tablets;|
| Placebo Comparator: Placebo SL Tablet<br>1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks | Drug: Placebo SL Tablet<br>* Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.<br>* Other names: Placebo sublingual tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average perceived pain | 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 severity score using an 11-point (0-10) NRS. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Global Impression of Change (PGIC) | Proportion of patients with a PGIC of very much improved or much improved rating at Week 12 | Week 12 | 
| Fibromyalgia Impact Questionnaire (FIQR) | Change from Baseline in the FIQR total score at Week12 | Week 12 | 
| Patient Reported Outcomes Measurement System (PROMIS) | Change from baseline in the PROMIS score for sleep disturbance at Week 12 | Week 12 | 
| Daily Diary sleep | Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12 | Week 12 | 
| Patient Reported Outcomes Measurement System (PROMIS) | Change from Baseline in the PROMIS score for fatigue at Week 12 | Week 12 | 
| Daily Diary pain | Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score | Week 12 | 
| Safety of TNX-102 SL Tablets | Incidence of adverse events | Continuously throughout the treatment period (total duration: about 3 months) | 
| Safety of TNX-102 SL Tablets assessed by changes from baseline in clinical laboratory tests |  | Continuously throughout the treatment period (total duration: about 3 months) | 
| Safety of TNX-102 SL Tablets assessed by changes from baseline in vital signs |  | Continuously throughout the treatment period (total duration: about 3 months) | 
| Safety of TNX-102 SL Tablets assessed by changes from baseline in physical examination findings including examination of the oral cavity |  | Continuously throughout the treatment period (total duration: about 3 months) | 
| Safety of TNX-102 SL Tablets assessed by Monitoring suicidality using the C-SSRS scale |  | Continuously throughout the treatment period (total duration: about 3 months) | 
| Safety of TNX-102 Sub lingual (SL) Tablets assessed by changes from baseline in BDI scores. |  | Continuously throughout the treatment period (total duration: about 3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Sleep