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BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT) (BESTFIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01903265
Recruitment Status : Completed
First Posted : July 19, 2013
Results First Posted : December 23, 2016
Last Update Posted : December 23, 2016
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Brief Summary:
TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was 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
Primary Fibromyalgia Drug: TNX-102 SL 2.8mg Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken at Bedtime in Patients With Fibromyalgia
Study Start Date : September 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: TNX-102 SL 2.8 mg
Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks.
Drug: TNX-102 SL 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
Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks.
Drug: Placebo
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. Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12 [ Time Frame: Baseline, Week 12 ]
    Daily pain scores were assessed using a 24-hour recall response provided by each patient via an interactive voice response system (IVRS) daily telephone diary. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Jump to control was used to replace missing data in each treatment arm.

Secondary Outcome Measures :
  1. 30% Responder Analysis of IVRS NRS Pain Assessments at Week 12 [ Time Frame: Baseline, Week 12 ]

    The weekly averages of daily pain scores were calculated using the daily, 24-hour-recall, IVRS NRS pain assessments.

    Patients who had at least a 30% improvement from baseline to week 12 in weekly average of daily pain scores were considered responders.

  2. Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance [ Time Frame: Baseline, Week 12 ]
    The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).

  3. Patient Global Impression of Change (PGIC) Responder Status ("Very Much Improved" or "Much Improved" vs All Other Categories) at Week 12 [ Time Frame: Week 12 ]
    The PGIC is a 7-point scale (1=very much improved; 7=very much worse) that assesses the patient's perception of the overall change in his/her fibromyalgia symptoms since entering the study. Scores of 1 and 2 were considered responders.

  4. Change From Baseline to Week 12 in FIQ-R Total Score [ Time Frame: Baseline, Week 12 ]
    The Fibromyalgia Impact Questionnaire (revised) FIQ-R is made up of 3 domains: functional (9 questions), overall (2 questions) and symptoms (10 questions). All questions are based on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." Total FIQ-R scores can range from 0-100, with higher scores reflecting worsening status. The patient's total score on the FIQ-R was assessed at Visits 2, 3, 4, 5, and 6 (Week 12). Jump to control was used to replace missing data in each treatment arm.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of primary Fibromyalgia (ACR criteria)
  • Male or female 18-65 years old
  • For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent 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.
  • Inability to wash-off specific medications (ask PI)
  • Known hypersensitivity to cyclobenzaprine
  • Others: seizure disorders, sleep apnea, continuous positive airway pressure (CPAP) use, 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 identifier (NCT number): NCT01903265

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United States, California
107 Scripps Drive
Sacramento, California, United States, 95825
United States, Colorado
Radiant Research, Inc.
Denver, Colorado, United States, 80239
United States, Florida
16176 Cortez Boulevard
Brooksville, Florida, United States, 34601
100 West Gore Street
Orlando, Florida, United States, 32806
United States, Illinois
3401 North Central Avenue
Chicago, Illinois, United States, 60634
United States, Maryland
71 Thomas Johnson Drive
Frederick, Maryland, United States, 21702
United States, Massachusetts
370 Faunce Corner Road
North Dartmouth, Massachusetts, United States, 02747
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01605
United States, Mississippi
CRC of Jackson, LLC
Jackson, Mississippi, United States, 39202
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45219
1275 Olentangy River Road
Columbus, Ohio, United States, 43212
18660 Bagley Road
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
1001 South Market Street
Mechanicsburg, Pennsylvania, United States, 17055
United States, South Carolina
322 Memorial Drive
Greer, South Carolina, United States, 29650
United States, Utah
1002 E. South Temple
Salt Lake City, Utah, United States, 84102
United States, Washington
1951 152nd Place NE
Bellevue, Washington, United States, 98007
601 Broadway
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
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Study Director: Mark R. Schmal Premier Research Group plc
Study Chair: Daniel J. Clauw, MD Ann Arbor, MI

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Responsible Party: Tonix Pharmaceuticals, Inc. Identifier: NCT01903265     History of Changes
Other Study ID Numbers: TNX-CY-F202
First Posted: July 19, 2013    Key Record Dates
Results First Posted: December 23, 2016
Last Update Posted: December 23, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Tonix Pharmaceuticals, Inc.:
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System 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