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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04508621
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: TNX-102 SL Drug: Placebo SL Tablet Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 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 Taken Daily At Bedtime In Patients With Fibromyalgia
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: TNX-102 SL Tablet, 2.8 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.
Drug: TNX-102 SL
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.
Other Name: 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.
Drug: Placebo SL Tablet
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.
Other Name: Placebo sublingual tablets




Primary Outcome Measures :
  1. Mean Pain Score [ Time Frame: Week 14 ]
    Change from Baseline to the Week 14 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome.


Secondary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire - Revised (FIQ-R) [ Time Frame: Week 14 ]
    Change from Baseline in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) symptoms domain score at the Week 14 endpoint. Scores on the symptoms domain range from 0 to 90 where a higher score means worse outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 defined range.

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508621


Contacts
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Contact: Mary Kelley, MPH 6193955767 mary.kelley@tonixpharma.com

Locations
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United States, Alabama
Tonix Clinical Site Recruiting
Birmingham, Alabama, United States, 35216
United States, Arizona
Tonix Clinical Site Recruiting
Phoenix, Arizona, United States, 85016
United States, California
Tonix Clinical Site Recruiting
Oceanside, California, United States, 92056
Tonix Clinical Site Recruiting
San Diego, California, United States, 92103
Tonix Clinical Site Recruiting
Santa Ana, California, United States, 92705
Tonix Clinical Site Recruiting
Temecula, California, United States, 32591
United States, Connecticut
Tonix Clinical Site Recruiting
Cromwell, Connecticut, United States, 06416
United States, Florida
Tonix Clinical Site Recruiting
Fort Myers, Florida, United States, 33912
Tonix Clinical Site Recruiting
Jacksonville, Florida, United States, 32256
Tonix Clinical Site Recruiting
North Miami, Florida, United States, 33161
Tonix Clinical Site Recruiting
Ocala, Florida, United States, 34470
Tonix Clinical Site Recruiting
Orlando, Florida, United States, 32801
United States, Georgia
Tonix Clinical Site Recruiting
Alpharetta, Georgia, United States, 30022
United States, Indiana
Tonix Clinical Site Recruiting
Evansville, Indiana, United States, 47714
United States, Iowa
Tonix Clinical Site Recruiting
West Des Moines, Iowa, United States, 50265
United States, Kansas
Tonix Clinical Site Recruiting
Prairie Village, Kansas, United States, 66208
United States, Louisiana
Tonix Clinical Site Recruiting
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Tonix Clinical Site Recruiting
Boston, Massachusetts, United States, 02131
United States, New Mexico
Tonix Clinical Site Recruiting
Albuquerque, New Mexico, United States, 87109
United States, New York
Tonix Clinical Site Recruiting
Williamsville, New York, United States, 14221
United States, North Carolina
Tonix Clinical Site Recruiting
High Point, North Carolina, United States, 27262
Tonix Clinical Site Not yet recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
Tonix Clinical Site Recruiting
Cincinnati, Ohio, United States, 45219
Tonix Clinical Site Recruiting
Dayton, Ohio, United States, 45417
Tonix Clinical Site Recruiting
North Canton, Ohio, United States, 44720
United States, Oklahoma
Tonix Clinical Site Recruiting
Oklahoma City, Oklahoma, United States, 73112
Tonix Clinical Site Recruiting
Tulsa, Oklahoma, United States, 74133
United States, Oregon
Tonix Clinical Site Recruiting
Portland, Oregon, United States, 97210
United States, Rhode Island
Tonix Clinical Site Recruiting
Warwick, Rhode Island, United States, 02886
United States, Tennessee
Tonix Clinical Site Recruiting
Chattanooga, Tennessee, United States, 37421
Tonix Clinical Site Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Tonix Clinical Site Recruiting
Austin, Texas, United States, 78737
Tonix Clinical Site Recruiting
Dallas, Texas, United States, 75231
United States, Utah
Tonix Clinical Site Recruiting
Salt Lake City, Utah, United States, 84102
United States, Virginia
Tonix Clinical Site Recruiting
Charlottesville, Virginia, United States, 22911
United States, Wisconsin
Tonix Clinical Site Recruiting
Kenosha, Wisconsin, United States, 53144
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Investigators
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Study Director: Gregory Sullivan, MD Tonix Pharmaceuticals, Inc.
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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04508621    
Other Study ID Numbers: TNX-CY-F306
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tonix Pharmaceuticals, Inc.:
Pain
Sleep
Fibromyalgia
FM
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System 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