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

October 31, 2016 updated by: Tonix Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Placebo sublingual tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 12
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).
Baseline, Week 12
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.
Week 12
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.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tonix Pharmaceuticals, Inc.

Investigators

  • Study Director: Mark R. Schmal, Premier Research Group plc
  • Study Chair: Daniel J. Clauw, MD, Ann Arbor, MI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (ESTIMATE)

July 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNX-CY-F202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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