BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)
- Conditions
- Primary Fibromyalgia
- Interventions
- Drug: TNX-102 SL 2.8mgDrug: Placebo
- Registration Number
- NCT01903265
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 205
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TNX-102 SL 2.8 mg TNX-102 SL 2.8mg Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks. Placebo Placebo Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12 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
Name Time Method 30% Responder Analysis of IVRS NRS Pain Assessments at Week 12 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 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 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 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.
Trial Locations
- Locations (17)
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
CRC of Jackson, LLC
🇺🇸Jackson, Mississippi, United States
1275 Olentangy River Road
🇺🇸Columbus, Ohio, United States
107 Scripps Drive
🇺🇸Sacramento, California, United States
1001 South Market Street
🇺🇸Mechanicsburg, Pennsylvania, United States
322 Memorial Drive
🇺🇸Greer, South Carolina, United States
100 West Gore Street
🇺🇸Orlando, Florida, United States
Radiant Research, Inc.
🇺🇸Denver, Colorado, United States
University of Cincinnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
1002 E. South Temple
🇺🇸Salt Lake City, Utah, United States
16176 Cortez Boulevard
🇺🇸Brooksville, Florida, United States
370 Faunce Corner Road
🇺🇸North Dartmouth, Massachusetts, United States
3401 North Central Avenue
🇺🇸Chicago, Illinois, United States
71 Thomas Johnson Drive
🇺🇸Frederick, Maryland, United States
18660 Bagley Road
🇺🇸Middleburg Heights, Ohio, United States
601 Broadway
🇺🇸Seattle, Washington, United States
1951 152nd Place NE
🇺🇸Bellevue, Washington, United States