A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

NCT04508621 | Completed Phase 3 Results FDA Drug

• 1 other identifier: TNX-CY-F306
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 36

Brief Summary

This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.

Conditions

Fibromyalgia

Keywords

Pain; Sleep; Fibromyalgia; FM

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.

  Patients provide a daily numeric assessment of their average pain (24-hour recall), via an electronic diary, using an 11-point NRS. Scores range from 0 (no pain) to 10 (worst possible pain).

  14 weeks

Secondary Outcomes (6)

• Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved"

  14 weeks

• Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score.

  14 weeks

• Change From Baseline to Week 14 in the FIQ-R Function Domain Score

  14 weeks

• Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance

  14 weeks

• Change From Baseline to Week 14 in the PROMIS Score for Fatigue

  14 weeks

Study Arms (2)

TNX-102 SL Tablet, 5.6 mg

EXPERIMENTAL

1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.

Drug: TNX-102 SL

Placebo SL Tablet

PLACEBO COMPARATOR

1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.

Drug: Placebo SL Tablet

Interventions

TNX-102 SL DRUG

Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.

Also known as: Low dose cyclobenzaprine sublingual tablets

TNX-102 SL Tablet, 5.6 mg

Placebo SL Tablet DRUG

Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.

Also known as: Placebo sublingual tablets

Placebo SL Tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is male or female 18 to 65 years of age, inclusive.
• The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
• The in clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol defined range.

You may not qualify if:

• \- History of or evidence for a diagnosis of borderline personality disorder (BPD).

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead

Study Sites (36)

Tonix Clinical Site

Birmingham, Alabama, 35216, United States

Location

Tonix Clinical Site

Phoenix, Arizona, 85016, United States

Location

Tonix Clinical Site

Oceanside, California, 92056, United States

Location

Tonix Clinical Site

San Diego, California, 92103, United States

Location

Tonix Clinical Site

Santa Ana, California, 92705, United States

Location

Tonix Clinical Site

Temecula, California, 32591, United States

Location

Tonix Clinical Site

Cromwell, Connecticut, 06416, United States

Location

Tonix Clinical Site

Fort Myers, Florida, 33912, United States

Location

Tonix Clinical Site

Jacksonville, Florida, 32256, United States

Location

Tonix Clinical Site

North Miami, Florida, 33161, United States

Location

Tonix Clinical Site

Ocala, Florida, 34470, United States

Location

Tonix Clinical Site

Orlando, Florida, 32801, United States

Location

Tonix Clinical Site

Alpharetta, Georgia, 30022, United States

Location

Tonix Clinical Site

Evansville, Indiana, 47714, United States

Location

Tonix Clinical Site

West Des Moines, Iowa, 50265, United States

Location

Tonix Clinical Site

Prairie Village, Kansas, 66208, United States

Location

Tonix Clinical Site

New Orleans, Louisiana, 70115, United States

Location

Tonix Clinical Site

Boston, Massachusetts, 02131, United States

Location

Tonix Clinical Site

Albuquerque, New Mexico, 87109, United States

Location

Tonix Clinical Site

Williamsville, New York, 14221, United States

Location

Tonix Clinical Site

High Point, North Carolina, 27262, United States

Location

Tonix Clinical Site

Raleigh, North Carolina, 27612, United States

Location

Tonix Clinical Site

Cincinnati, Ohio, 45219, United States

Location

Tonix Clinical Site

Dayton, Ohio, 45417, United States

Location

Tonix Clinical Site

North Canton, Ohio, 44720, United States

Location

Tonix Clinical Site

Oklahoma City, Oklahoma, 73112, United States

Location

Tonix Clinical Site

Tulsa, Oklahoma, 74133, United States

Location

Tonix Clinical Site

Portland, Oregon, 97210, United States

Location

Tonix Clinical Site

Warwick, Rhode Island, 02886, United States

Location

Tonix Clinical Site

Chattanooga, Tennessee, 37421, United States

Location

Tonix Clinical Site

Memphis, Tennessee, 38119, United States

Location

Tonix Clinical Site

Austin, Texas, 78737, United States

Location

Tonix Clinical Site

Dallas, Texas, 75231, United States

Location

Tonix Clinical Site

Salt Lake City, Utah, 84102, United States

Location

Tonix Clinical Site

Charlottesville, Virginia, 22911, United States

Location

Tonix Clinical Site

Kenosha, Wisconsin, 53144, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Recruitment during COVID-19 pandemic

Results Point of Contact

• Title: Gregory Sullivan, MD
• Organization: Tonix Pharmaceuticals

Greg.Sullivan@TonixPharma.com

(862) 904-0355

Study Officials

• Gregory Sullivan, MD

  Tonix Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 11, 2020
• Study Start: July 22, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: December 18, 2023
• Results First Posted: December 2, 2022

Record last verified: 2023-12

Locations

US (36)