Trial record 7 of 134 for:    fibromyalgia | Open Studies | Interventional Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Tonix Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02829814
First received: July 8, 2016
Last updated: July 21, 2016
Last verified: July 2016
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Tonix Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Weekly mean pain score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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:
  • Patient's Global Impression of Change (PGIC) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Proportion of patients with a PGIC rating of "very much improved" or "much improved" at Week 12

  • Fibromyalgia Impact Questionnaire (FIQR) Revised [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Change from Baseline in the FIQR symptoms domain score at Week 12

  • Fibromyalgia Impact Questionnaire (FIQR) Revised [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Change from Baseline in the FIQR function domain score at Week 12

  • Daily Diary Sleep [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12

  • Patient Reported Outcomes Measurement System (PROMIS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Change from Baseline in the PROMIS score for sleep disturbance at Week 12

  • Patient Reported Outcomes Measurement System (PROMIS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Change from Baseline in the PROMIS score for fatigue at Week 12

  • Daily Diary Pain [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score


Other Outcome Measures:
  • Safety of TNX-102 SL Tablets (Incidence of Adverse Events) [ Time Frame: Continuously throughout the treatment period (total duration: about 3 months) ] [ Designated as safety issue: Yes ]
    Incidence of Adverse Events

  • 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) ] [ Designated as safety issue: Yes ]
    Changes from Baseline in clinical laboratory tests

  • Safety of TNX-102 SL Tablets (Changes from Baseline in vital signs) [ Time Frame: Continuously throughout the treatment period (total duration: about 3 months) ] [ Designated as safety issue: Yes ]
    Changes from Baseline in vital signs

  • 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) ] [ Designated as safety issue: Yes ]
    Changes from Baseline in physical examination findings including examination of the oral cavity

  • Safety of TNX-102 SL Tablets (Monitoring suicidality using the C-SSRS) [ Time Frame: Continuously throughout the treatment period (total duration: about 3 months) ] [ Designated as safety issue: Yes ]
    Monitoring suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)

  • 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) ] [ Designated as safety issue: Yes ]
    Changes from Baseline in Beck Depression Inventory Scores (BDI-II) scores


Estimated Enrollment: 500
Study Start Date: July 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • Tonmya® (cyclobenzaprine HCl 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02829814

Contacts
Contact: Jill Smith 512.528.5282 Jill.Smith@premier-research.com

  Show 32 Study Locations
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
  More Information

Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02829814     History of Changes
Other Study ID Numbers: TNX-CY-F302 
Study First Received: July 8, 2016
Last Updated: July 21, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Tonix Pharmaceuticals, Inc.:
Pain
Sleep
Fibromyalgia
FM

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
Amitriptyline
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
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 28, 2016