Skip to main content
OpenTrials
Completed

NCT Number: NCT01903265

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Fibromyalgia Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

107 Scripps Drive, Sacramento, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TNX-102 SL 2.8mg

Drug

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

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tonix Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: BESTFIT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 19, 2013
Registry last updated
Dec 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.