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A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia (AFFIRM)

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ClinicalTrials.gov Identifier: NCT02436096
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

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
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Drug: TNX-102 SL Tablet, 2.8mg Drug: Placebo SL Tablet Phase 3

Study Type : Interventional  (Clinical Trial)
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 : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

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 Name: 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 Name: Placebo sublingual tablets



Primary Outcome Measures :
  1. Average perceived pain [ Time Frame: 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) [ Time Frame: Week 12 ]
    Proportion of patients with a PGIC of "very much improved" or "much improved" rating at Week 12

  2. Fibromyalgia Impact Questionnaire (FIQR) [ Time Frame: Week 12 ]
    Change from Baseline in the FIQR total score at Week12

  3. Patient Reported Outcomes Measurement System (PROMIS) [ Time Frame: Week 12 ]
    Change from baseline in the PROMIS score for sleep disturbance at Week 12

  4. Daily Diary sleep [ Time Frame: 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) [ Time Frame: Week 12 ]
    Change from Baseline in the PROMIS score for fatigue at Week 12

  6. Daily Diary pain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: Continuously throughout the treatment period (total duration: about 3 months) ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02436096


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Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.

Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02436096     History of Changes
Other Study ID Numbers: TNX-CY-F301
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

Keywords provided by Tonix Pharmaceuticals, Inc.:
Pain
Sleep

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Muscular Diseases
Connective Tissue 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