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Trial record 27 of 46 for:    CYCLOBENZAPRINE

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

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ClinicalTrials.gov Identifier: NCT02829814
Recruitment Status : Terminated (For business reason unrelated to safety or tolerability,Tonix has discontinued the Fibromyalgia development with TNX102 SL.)
First Posted : July 12, 2016
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

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

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Study Type : Interventional  (Clinical Trial)
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 : July 2016
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

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 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. Weekly mean pain score [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Week 12 ]
    Change from Baseline in the FIQR symptoms domain score at Week 12

  3. Fibromyalgia Impact Questionnaire (FIQR) Revised [ Time Frame: Week 12 ]
    Change from Baseline in the FIQR function domain score 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 sleep disturbance at Week 12

  6. Patient Reported Outcomes Measurement System (PROMIS) [ Time Frame: Week 12 ]
    Change from Baseline in the PROMIS score for fatigue at Week 12

  7. 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


Other Outcome Measures:
  1. Safety of TNX-102 SL Tablets (Incidence of Adverse Events) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Continuously throughout the treatment period (total duration: about 3 months) ]
    Changes from Baseline in Beck Depression Inventory Scores (BDI-II) scores



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
  • 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

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): NCT02829814


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Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.

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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02829814     History of Changes
Other Study ID Numbers: TNX-CY-F302
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Keywords provided by Tonix Pharmaceuticals, Inc.:
Pain
Sleep
Fibromyalgia
FM
Additional relevant MeSH terms:
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Cyclobenzaprine
Fibromyalgia
Myofascial Pain Syndromes
Rheumatic Diseases
Muscular Diseases
Neuromuscular Diseases
Collagen Diseases
Nervous System Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
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