A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia (RELIEF)

July 13, 2022 updated by: Tonix Pharmaceuticals, Inc.

A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

503

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Tonix Clinical Site
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Tonix Clinical Site
    • California
      • Oceanside, California, United States, 92056
        • Tonix Clinical Site
      • Sacramento, California, United States, 95831
        • Tonix Clinical Site
      • San Diego, California, United States, 92103
        • Tonix Clinical Site
      • Temecula, California, United States, 32591
        • Tonix Clinical Site
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Tonix Clinical Site
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Tonix Clinical Site
      • Jacksonville, Florida, United States, 32256
        • Tonix Clinical Site
      • North Miami, Florida, United States, 33161
        • Tonix Clinical Site
      • Ocala, Florida, United States, 34470
        • Tonix Clinical Site
      • Orlando, Florida, United States, 32801
        • Tonix Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Tonix Clinical Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Tonix Clinical Site
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Tonix Clinical Site
    • Kansas
      • Prairie Village, Kansas, United States, 66208
        • Tonix Clinical Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Tonix Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Tonix Clinical Site
      • North Dartmouth, Massachusetts, United States, 02747
        • Tonix Clinical Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Tonix Clinical Site
    • New York
      • Williamsville, New York, United States, 14221
        • Tonix Clinical Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Tonix Clinical Site
      • Raleigh, North Carolina, United States, 27612
        • Tonix Clinical Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Tonix Clinical Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Tonix Clinical Site
      • Dayton, Ohio, United States, 45417
        • Tonix Clinical Site
      • North Canton, Ohio, United States, 44720
        • Tonix Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Tonix Clinical Site
      • Tulsa, Oklahoma, United States, 74133
        • Tonix Clinical Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Tonix Clinical Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Tonix Clinical Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Tonix Clinical Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Tonix Clinical Site
      • Memphis, Tennessee, United States, 38119
        • Tonix Clinical Site
    • Texas
      • Austin, Texas, United States, 78737
        • Tonix Clinical Site
      • Dallas, Texas, United States, 75231
        • Tonix Clinical Site
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Tonix Clinical Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Tonix Clinical Site
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • Tonix Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 specified range.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TNX-102 SL Tablets, 5.6 mg
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.
Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets 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 2 weeks then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
Other Names:
  • Placebo sublingual tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.
Time Frame: 14 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved"
Time Frame: 14 weeks
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 a much worse outcome.
14 weeks
Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score
Time Frame: 14 weeks
The FIQ-R is a validated questionnaire. Scores on the symptoms domain range from 0 to 100 where a higher score means worse outcome.
14 weeks
Change From Baseline to Week 14 in the FIQR Function Domain Score
Time Frame: 14 weeks
The FIQ-R is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome.
14 weeks
Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance
Time Frame: 14 weeks
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.
14 weeks
Change From Baseline to Week 14 in the PROMIS Score for Fatigue
Time Frame: 14 weeks
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.
14 weeks
Change From Baseline to Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality
Time Frame: 14 weeks
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).
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Gregory Sullivan, MD, Tonix Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2019

Primary Completion (Actual)

October 29, 2020

Study Completion (Actual)

October 29, 2020

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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