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

Sponsor
Tonix Pharmaceuticals, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04508621
Collaborator
(none)
514
Enrollment
36
Locations
2
Arms
15.3
Actual Duration (Months)
14.3
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: TNX-102 SL
  • Drug: Placebo SL Tablet
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
514 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 :
Jul 22, 2020
Actual Primary Completion Date :
Nov 1, 2021
Actual Study Completion Date :
Nov 1, 2021

Arms and Interventions

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 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.

    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 Names:
  • Placebo sublingual tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean Pain Score [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) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tonix Clinical Site Birmingham Alabama United States 35216
    2 Tonix Clinical Site Phoenix Arizona United States 85016
    3 Tonix Clinical Site Oceanside California United States 92056
    4 Tonix Clinical Site San Diego California United States 92103
    5 Tonix Clinical Site Santa Ana California United States 92705
    6 Tonix Clinical Site Temecula California United States 32591
    7 Tonix Clinical Site Cromwell Connecticut United States 06416
    8 Tonix Clinical Site Fort Myers Florida United States 33912
    9 Tonix Clinical Site Jacksonville Florida United States 32256
    10 Tonix Clinical Site North Miami Florida United States 33161
    11 Tonix Clinical Site Ocala Florida United States 34470
    12 Tonix Clinical Site Orlando Florida United States 32801
    13 Tonix Clinical Site Alpharetta Georgia United States 30022
    14 Tonix Clinical Site Evansville Indiana United States 47714
    15 Tonix Clinical Site West Des Moines Iowa United States 50265
    16 Tonix Clinical Site Prairie Village Kansas United States 66208
    17 Tonix Clinical Site New Orleans Louisiana United States 70115
    18 Tonix Clinical Site Boston Massachusetts United States 02131
    19 Tonix Clinical Site Albuquerque New Mexico United States 87109
    20 Tonix Clinical Site Williamsville New York United States 14221
    21 Tonix Clinical Site High Point North Carolina United States 27262
    22 Tonix Clinical Site Raleigh North Carolina United States 27612
    23 Tonix Clinical Site Cincinnati Ohio United States 45219
    24 Tonix Clinical Site Dayton Ohio United States 45417
    25 Tonix Clinical Site North Canton Ohio United States 44720
    26 Tonix Clinical Site Oklahoma City Oklahoma United States 73112
    27 Tonix Clinical Site Tulsa Oklahoma United States 74133
    28 Tonix Clinical Site Portland Oregon United States 97210
    29 Tonix Clinical Site Warwick Rhode Island United States 02886
    30 Tonix Clinical Site Chattanooga Tennessee United States 37421
    31 Tonix Clinical Site Memphis Tennessee United States 38119
    32 Tonix Clinical Site Austin Texas United States 78737
    33 Tonix Clinical Site Dallas Texas United States 75231
    34 Tonix Clinical Site Salt Lake City Utah United States 84102
    35 Tonix Clinical Site Charlottesville Virginia United States 22911
    36 Tonix Clinical Site Kenosha Wisconsin United States 53144

    Sponsors and Collaborators

    • Tonix Pharmaceuticals, Inc.

    Investigators

    • Study Director: Gregory Sullivan, MD, Tonix Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tonix Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT04508621
    Other Study ID Numbers:
    • TNX-CY-F306
    First Posted:
    Aug 11, 2020
    Last Update Posted:
    Dec 13, 2021
    Last Verified:
    Nov 1, 2021
    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:
    Fibromyalgia
    Myofascial Pain Syndromes
    Cyclobenzaprine

    Study Results

    No Results Posted as of Dec 13, 2021