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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01903265
First received: July 12, 2013
Last updated: October 31, 2016
Last verified: October 2016

July 12, 2013
Not Provided
September 2013
July 2014   (Final data collection date for primary outcome measure)
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.
Patient-Perceived Pain [ Time Frame: Weeks 12 or early termination mean change of perceived average pain intensity from baseline ]
The weekly mean change from baseline of the daily patient-perceived average pain intensity will be assesed from the records of the 24-hour recall responses of the patient via a daily telephone diary, using an 11-point numeric assessment of their pain (0=no pain to 10=worst possible pain). Patients will be asked to complete this assessment on a daily basis during the pre-treatment run-in period and throughout the double-blind treatment period
No Changes Posted
  • 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.

  • 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).
  • 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.
  • 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.
  • Patient's Global Impression of Change [ Time Frame: Weeks 2, 4, 8 and 12 or early termination ]
  • Fibromyalgia Impact Questionnaire [ Time Frame: Baseline and weeks 2, 4, 8 and 12 ]
  • Patient pain improvement response rate [ Time Frame: Weekly ]
  • SF-36 Physical Component score [ Time Frame: Baseline and weeks 4, 8 and 12 ]
  • Safety of TNX-102 SL Tablets [ Time Frame: Continuously throughout the treatment period (total duration: about 3 months) ]
    Every adverse events occurring during the study period will be reported.
Not Provided
Not Provided
 
BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Fibromyalgia
  • 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
  • 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
  • Experimental: TNX-102 SL 2.8 mg
    Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks.
    Intervention: Drug: TNX-102 SL 2.8mg
  • Placebo Comparator: Placebo
    Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
205
September 2014
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01903265
TNX-CY-F202
No
Not Provided
Undecided
Not Provided
Tonix Pharmaceuticals, Inc.
Tonix Pharmaceuticals, Inc.
Not Provided
Study Director: Mark R. Schmal Premier Research Group plc
Study Chair: Daniel J. Clauw, MD Ann Arbor, MI
Tonix Pharmaceuticals, Inc.
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP