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

Tonix Pharmaceuticals, Inc.519 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

519

Conditions

Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Nervous System Diseases

Interventions

TNX-102 SL Tablet, 2.8mgDRUG

Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.

Placebo SL TabletDRUG

Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. * Inability to wash-out specific medications (ask PI) * Known hypersensitivity to cyclobenzaprine * Others: seizure disorders, severe/untreated sleep apnea, BMI\>40

Locations (35)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Sacramento, California, United States

Unnamed facility

San Diego, California, United States

Unnamed facility

Brandon, Florida, United States

Unnamed facility

DeLand, Florida, United States

Unnamed facility

Lakeland, Florida, United States

Unnamed facility

Ocala, Florida, United States

Unnamed facility

Orlando, Florida, United States

Unnamed facility

Tampa, Florida, United States

...and 25 more locations

Outcomes

Primary Outcomes

Proportion of Patients With ≥30% Pain Improvement

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 intensity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain).

Time frame: Day 1, Week 12

Secondary Outcomes

Patient's Global Impression of Change (PGIC)

Proportion of patients with a PGIC rating of 1 ("very much improved") or 2 ("much improved") at Week 12. The PGIC is a fibromyalgia specific validated instrument on a scale of 1 to 7, where a score of 1 indicates the highest level of improvement and a score of 7 indicates the highest level of worsening.

Time frame: Week 12

Change From Baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score

The FIQR is a validated questionnaire. Scores on the symptoms domain range from 0 to 100 where a higher score means worse outcome.

Time frame: Day 1, Week 12

Change From Baseline to Week 12 in the FIQR Function Domain Score

The FIQR is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome.

Time frame: Day 1, Week 12

Patient Reported Outcomes Measurement System (PROMIS) Sleep Disturbance

Change from baseline in the PROMIS score for sleep disturbance at Week 12. The PROMIS Sleep disturbance short form 8a consists of 8 questions on a 5-point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. Lower T-scores indicate less sleep disturbance.

Time frame: Day 1, Week 12

Weekly Average of Daily Sleep Quality Diary

Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12. Patients provide a daily numeric assessment of their sleep quality for the previous night, via an electronic diary, using an 11-point NRS. Scores range from 0 (best possible sleep) to 10 (worst possible sleep).

Time frame: Baseline (Day -7 to Day -1), Week 12

Patient Reported Outcomes Measurement System (PROMIS) Fatigue

Change from Baseline in the PROMIS score for fatigue at Week 12. The PROMIS fatigue short form 8a consists of 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. Lower T-scores indicate less fatigue.

Time frame: Day 1, Week 12

Weekly Average of Daily Pain Diary

Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain).

Time frame: Baseline (Day -7 to Day -1), Week 12