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RE-AFFIRM: Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia

Sponsor
Tonix Pharmaceuticals, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02829814
Collaborator
(none)
51
Enrollment
32
Locations
2
Arms
2
Duration (Months)
1.6
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.

The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

Condition or Disease Intervention/Treatment Phase
  • Drug: TNX-102 SL Tablet, 2.8 mg
  • Drug: Placebo SL Tablet
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
51 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 :
Jul 1, 2016
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

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 12 weeks

Drug: TNX-102 SL Tablet, 2.8 mg
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 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 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 Names:
  • Placebo sublingual tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Weekly mean pain score [Week 12]

      The primary efficacy endpoint is the proportion of patients with a ≥30% improvement from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) numeric response scale (NRS).

    Secondary Outcome Measures

    1. Patient's Global Impression of Change (PGIC) [Week 12]

      Proportion of patients with a PGIC rating of "very much improved" or "much improved" at Week 12

    2. Fibromyalgia Impact Questionnaire (FIQR) Revised [Week 12]

      Change from Baseline in the FIQR symptoms domain score at Week 12

    3. Fibromyalgia Impact Questionnaire (FIQR) Revised [Week 12]

      Change from Baseline in the FIQR function domain score at Week 12

    4. Daily Diary Sleep [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) [Week 12]

      Change from Baseline in the PROMIS score for sleep disturbance at Week 12

    6. Patient Reported Outcomes Measurement System (PROMIS) [Week 12]

      Change from Baseline in the PROMIS score for fatigue at Week 12

    7. Daily Diary Pain [Week 12]

      Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score

    Other Outcome Measures

    1. Safety of TNX-102 SL Tablets (Incidence of Adverse Events) [Continuously throughout the treatment period (total duration: about 3 months)]

      Incidence of Adverse Events

    2. Safety of TNX-102 SL Tablets (Changes from Baseline in clinical laboratory tests) [Continuously throughout the treatment period (total duration: about 3 months)]

      Changes from Baseline in clinical laboratory tests

    3. Safety of TNX-102 SL Tablets (Changes from Baseline in vital signs) [Continuously throughout the treatment period (total duration: about 3 months)]

      Changes from Baseline in vital signs

    4. Safety of TNX-102 SL Tablets (Changes from Baseline in physical examination findings including examination of the oral cavity) [Continuously throughout the treatment period (total duration: about 3 months)]

      Changes from Baseline in physical examination findings including examination of the oral cavity

    5. Safety of TNX-102 SL Tablets (Monitoring suicidality using the C-SSRS) [Continuously throughout the treatment period (total duration: about 3 months)]

      Monitoring suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)

    6. Safety of TNX-102 SL Tablets (Changes from Baseline in BDI-II scores) [Continuously throughout the treatment period (total duration: about 3 months)]

      Changes from Baseline in Beck Depression Inventory Scores (BDI-II) scores

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of Primary Fibromyalgia (2010 ACR criteria)

    • Male or female 18-75 years old

    • Patients currently receiving pharmacologic treatment for depression should have been clinically stable for at least 3 months prior to randomization, and on stable doses of antidepressants during this 3 month time frame.

    • Willing and able to withdraw specific therapies (ask PI)

    • If female, medically acceptable form of contraception or not of child bearing potential.

    • Provide written informed consent to participate.

    • Willing and able to comply with all protocol specified requirement.

    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.

    • Inability to wash-out specific medications (ask PI)

    • Known hypersensitivity to cyclobenzaprine

    • Others: seizure disorders, severe/untreated sleep apnea, BMI>45

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States 35216
    2 Phoenix Arizona United States 85032
    3 Oceanside California United States 92056
    4 San Diego California United States 92103
    5 Brandon Florida United States 33511
    6 DeLand Florida United States 32720
    7 Ocala Florida United States 34471
    8 Orlando Florida United States 32801
    9 Tampa Florida United States 33613
    10 Tampa Florida United States 33614
    11 West Palm Beach Florida United States 33409
    12 Evansville Indiana United States 47714
    13 Indianapolis Indiana United States 46260
    14 Jackson Mississippi United States 39202
    15 Las Vegas Nevada United States 89102
    16 Cedarhurst New York United States 11516
    17 Williamsville New York United States 14221
    18 Raleigh North Carolina United States 27612
    19 Fargo North Dakota United States 58103
    20 Canton Ohio United States 44718
    21 Cincinnati Ohio United States 45219
    22 Medford Oregon United States 97504
    23 Portland Oregon United States 97210
    24 Salem Oregon United States 97301
    25 Allentown Pennsylvania United States 18104
    26 Warwick Rhode Island United States 02888
    27 Mount Pleasant South Carolina United States 29464
    28 Chattanooga Tennessee United States 37421
    29 Dallas Texas United States 75231
    30 Salt Lake City Utah United States 84102
    31 Seattle Washington United States 98104
    32 Kenosha Wisconsin United States 53142

    Sponsors and Collaborators

    • Tonix Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tonix Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02829814
    Other Study ID Numbers:
    • TNX-CY-F302
    First Posted:
    Jul 12, 2016
    Last Update Posted:
    Apr 25, 2018
    Last Verified:
    Apr 1, 2018
    Keywords provided by Tonix Pharmaceuticals, Inc.
    Pain
    Sleep
    Fibromyalgia
    FM
    Additional relevant MeSH terms:
    Fibromyalgia
    Myofascial Pain Syndromes
    Rheumatic Diseases
    Musculoskeletal Diseases
    Muscular Diseases
    Nervous System Diseases
    Neuromuscular Diseases
    Collagen Diseases
    Cyclobenzaprine

    Study Results

    No Results Posted as of Apr 25, 2018