Clincosm LogoSign in Get a demo

AFFIRM: 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
Completed
CT.gov ID
NCT02436096
Collaborator
(none)
519
Enrollment
35
Locations
2
Arms
17.1
Duration (Months)
14.8
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

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

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

Study Design

Study Type:
Interventional
Actual Enrollment :
519 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 :
Apr 1, 2015
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 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks

Drug: TNX-102 SL Tablet, 2.8mg
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. Average perceived pain [Week 12]

      The primary efficacy endpoint is the proportion of patients with a ≥30% improvement (responder criteria) from baseline to Week 12 in the weekly mean of the daily self-reported 24-hour recall average pain severity score using an 11-point (0-10) NRS.

    Secondary Outcome Measures

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

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

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

      Change from Baseline in the FIQR total score at Week12

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

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

    6. Daily Diary pain [Week 12]

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

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

      Incidence of adverse events

    8. Safety of TNX-102 SL Tablets assessed by changes from baseline in clinical laboratory tests [Continuously throughout the treatment period (total duration: about 3 months)]

    9. Safety of TNX-102 SL Tablets assessed by changes from baseline in vital signs [Continuously throughout the treatment period (total duration: about 3 months)]

    10. Safety of TNX-102 SL Tablets assessed by changes from baseline in physical examination findings including examination of the oral cavity [Continuously throughout the treatment period (total duration: about 3 months)]

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

    12. Safety of TNX-102 Sub lingual (SL) Tablets assessed by changes from baseline in BDI scores. [Continuously throughout the treatment period (total duration: about 3 months)]

    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

    • For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressant therapy

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

    • Medically acceptable form of contraception (female only)

    • Signed informed consent

    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.

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

    • Known hypersensitivity to cyclobenzaprine

    • Others: seizure disorders, severe/untreated sleep apnea, BMI>40

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States 35216
    2 Phoenix Arizona United States 85032
    3 Sacramento California United States 95825
    4 San Diego California United States 92103
    5 Brandon Florida United States 33511
    6 DeLand Florida United States 32720
    7 Lakeland Florida United States 33805
    8 Ocala Florida United States 34471
    9 Orlando Florida United States 32806
    10 Tampa Florida United States 33613
    11 Tampa Florida United States 33614
    12 West Palm Beach Florida United States 33409
    13 Columbus Georgia United States 31904
    14 Smyrna Georgia United States 30080
    15 Evansville Indiana United States 47714
    16 North Dartmouth Massachusetts United States 02747
    17 Ann Arbor Michigan United States 48104
    18 Jackson Mississippi United States 39202
    19 Williamsville New York United States 14221
    20 Cincinnati Ohio United States 45206
    21 Columbus Ohio United States 43212
    22 Middleburg Heights Ohio United States 44130
    23 Medford Oregon United States 97504
    24 Portland Oregon United States 97210
    25 Allentown Pennsylvania United States 18104
    26 Warwick Rhode Island United States 02888
    27 Greer South Carolina United States 29650
    28 Mount Pleasant South Carolina United States 29464
    29 Dallas Texas United States 75231
    30 Salt Lake City Utah United States 84102
    31 Charlottesville Virginia United States 22911
    32 Norfolk Virginia United States 23507
    33 Bellevue Washington United States 98007
    34 Seattle Washington United States 98104
    35 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:
    NCT02436096
    Other Study ID Numbers:
    • TNX-CY-F301
    First Posted:
    May 6, 2015
    Last Update Posted:
    Dec 12, 2017
    Last Verified:
    Dec 1, 2017
    Keywords provided by Tonix Pharmaceuticals, Inc.
    Pain
    Sleep
    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 Dec 12, 2017