Repeat of: 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 present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia. The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

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

Intervention / Treatment
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* Drug: TNX-102 SL Tablet, 2.8 mg
* 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 Patients currently receiving pharmacologic treatment for depression should have been clinically stable for at least 3 months prior to randomization, and on stable doses of antidepressants during this 3 month time frame. Willing and able to withdraw specific therapies (ask PI) If female, medically acceptable form of contraception or not of child bearing potential. Provide written informed consent to participate. Willing and able to comply with all protocol specified requirement. 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. Inability to wash-out specific medications (ask PI) Known hypersensitivity to cyclobenzaprine Others: seizure disorders, severe/untreated sleep apnea, BMI>45

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 2.8 mg Tablet taken sublingually each day at bedtime for 12 weeks | Drug: TNX-102 SL Tablet, 2.8 mg<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 |
| --- | --- | --- |
| Weekly mean pain score | 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). | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Global Impression of Change (PGIC) | Proportion of patients with a PGIC rating of very much improved or much improved at Week 12 | Week 12 | 
| Fibromyalgia Impact Questionnaire (FIQR) Revised | Change from Baseline in the FIQR symptoms domain score at Week 12 | Week 12 | 
| Fibromyalgia Impact Questionnaire (FIQR) Revised | Change from Baseline in the FIQR function domain score 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 sleep disturbance 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 | 

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