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

• ClinicalTrials.gov Identifier: NCT02436096
• Recruitment Status: Completed
• First Posted: May 6, 2015
• Last Update Posted: December 12, 2017
• Sponsor: Tonix Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Tonix Pharmaceuticals, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Rheumatic Diseases	Drug: TNX-102 SL Tablet, 2.8mg; Drug: Placebo SL Tablet	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 519 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: April 2015
• Actual Primary Completion Date: September 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

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 0 for 12 weeks.; Other Name: 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 0 for 12 weeks.; Other Name: Placebo sublingual tablets

Outcome Measures

Primary Outcome Measures :

1. Average perceived pain [ Time Frame: Week 12 ]
   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.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Birmingham, Alabama, United States, 35216

United States, Arizona

Phoenix, Arizona, United States, 85032

United States, California

Sacramento, California, United States, 95825

San Diego, California, United States, 92103

United States, 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

United States, Georgia

Columbus, Georgia, United States, 31904

Smyrna, Georgia, United States, 30080

United States, Indiana

Evansville, Indiana, United States, 47714

United States, Massachusetts

North Dartmouth, Massachusetts, United States, 02747

United States, Michigan

Ann Arbor, Michigan, United States, 48104

United States, Mississippi

Jackson, Mississippi, United States, 39202

United States, New York

Williamsville, New York, United States, 14221

United States, Ohio

Cincinnati, Ohio, United States, 45206

Columbus, Ohio, United States, 43212

Middleburg Heights, Ohio, United States, 44130

United States, Oregon

Medford, Oregon, United States, 97504

Portland, Oregon, United States, 97210

United States, Pennsylvania

Allentown, Pennsylvania, United States, 18104

United States, Rhode Island

Warwick, Rhode Island, United States, 02888

United States, South Carolina

Greer, South Carolina, United States, 29650

Mount Pleasant, South Carolina, United States, 29464

United States, Texas

Dallas, Texas, United States, 75231

United States, Utah

Salt Lake City, Utah, United States, 84102

United States, Virginia

Charlottesville, Virginia, United States, 22911

Norfolk, Virginia, United States, 23507

United States, Washington

Bellevue, Washington, United States, 98007

Seattle, Washington, United States, 98104

United States, Wisconsin

Kenosha, Wisconsin, United States, 53142

Sponsors and Collaborators

Tonix Pharmaceuticals, Inc.

More Information

• Responsible Party: Tonix Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT02436096
• Other Study ID Numbers: TNX-CY-F301
• First Posted: May 6, 2015
• Last Update Posted: December 12, 2017
• Last Verified: December 2017

Keywords provided by Tonix Pharmaceuticals, Inc.:

Pain; Sleep

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Rheumatic Diseases; Musculoskeletal Diseases; Muscular Diseases; Nervous System Diseases; Neuromuscular Diseases; Collagen Diseases; Connective Tissue Diseases; Cyclobenzaprine; Antidepressive Agents, Tricyclic; Antidepressive Agents; Psychotropic Drugs; Muscle Relaxants, Central; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents; Tranquilizing Agents; Central Nervous System Depressants