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

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

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 Overview

• Status: Completed
• Conditions: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Intervention / Treatment: Drug: TNX-102 SL Tablet, 2.8mg; Drug: Placebo SL Tablet

• Study Type: Interventional
• Enrollment (Actual): 519
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
  • Arizona
    • Phoenix, Arizona, United States, 85032
  • California
    • Sacramento, California, United States, 95825
    • San Diego, California, United States, 92103
  • Florida
    • Brandon, Florida, United States, 33511
    • DeLand, Florida, United States, 32720
    • Lakeland, Florida, United States, 33805
    • Ocala, Florida, United States, 34471
    • Orlando, Florida, United States, 32806
    • Tampa, Florida, United States, 33613
    • Tampa, Florida, United States, 33614
    • West Palm Beach, Florida, United States, 33409
  • Georgia
    • Columbus, Georgia, United States, 31904
    • Smyrna, Georgia, United States, 30080
  • Indiana
    • Evansville, Indiana, United States, 47714
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
  • Mississippi
    • Jackson, Mississippi, United States, 39202
  • New York
    • Williamsville, New York, United States, 14221
  • Ohio
    • Cincinnati, Ohio, United States, 45206
    • Columbus, Ohio, United States, 43212
    • Middleburg Heights, Ohio, United States, 44130
  • Oregon
    • Medford, Oregon, United States, 97504
    • Portland, Oregon, United States, 97210
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
  • Rhode Island
    • Warwick, Rhode Island, United States, 02888
  • South Carolina
    • Greer, South Carolina, United States, 29650
    • Mount Pleasant, South Carolina, United States, 29464
  • Texas
    • Dallas, Texas, United States, 75231
  • Utah
    • Salt Lake City, Utah, United States, 84102
  • Virginia
    • Charlottesville, Virginia, United States, 22911
    • Norfolk, Virginia, United States, 23507
  • Washington
    • Bellevue, Washington, United States, 98007
    • Seattle, Washington, United States, 98104
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 1, 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 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.	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.	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.	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.	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).	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.	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).	Baseline (Day -7 to Day -1), Week 12

Collaborators and Investigators

• Sponsor: Tonix Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimated): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Sleep
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Rheumatic Diseases; Collagen Diseases; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Neuromuscular Agents; Muscle Relaxants, Central; Antidepressive Agents, Tricyclic; Cyclobenzaprine
• Other Study ID Numbers: TNX-CY-F301