Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia

Phase 3

Terminated

Conditions: Fibromyalgia
Muscular Diseases
Nervous System Diseases
Rheumatic Diseases
Myofascial Pain Syndromes
Neuromuscular Diseases
Musculoskeletal Diseases

Interventions: Drug: TNX-102 SL Tablet, 2.8 mg
Drug: Placebo SL Tablet

Registration Number: NCT02829814

Lead Sponsor: Tonix Pharmaceuticals, Inc.

Brief Summary: The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.

The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 51

Inclusion Criteria

Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
Male or female 18-75 years old
Patients currently receiving pharmacologic treatment for depression should have been clinically stable for at least 3 months prior to randomization, and on stable doses of antidepressants during this 3 month time frame.
Willing and able to withdraw specific therapies (ask PI)
If female, medically acceptable form of contraception or not of child bearing potential.
Provide written informed consent to participate.
Willing and able to comply with all protocol specified requirement.

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-out specific medications (ask PI)
Known hypersensitivity to cyclobenzaprine
Others: seizure disorders, severe/untreated sleep apnea, BMI>45

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNX-102 SL Tablet, 2.8 mg	TNX-102 SL Tablet, 2.8 mg	1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 12 weeks
Placebo SL Tablet	Placebo SL Tablet	1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks

Primary Outcome Measures

Name	Time	Method
Weekly Mean Pain Score	Day 1, Week 12	The primary efficacy endpoint is the proportion of patients with a ≥30% improvement from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) numeric response scale (NRS). A score of 0 indicates "no pain at all", and a score of 10 indicates "worst possible pain".

Secondary Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnaire (FIQR) Revised, Symptoms Domain	Day 1, Week 12	Change from Baseline in the FIQR symptoms domain score at Week 12. The FIQ-R symptom domain is composed of 10 questions. All questions are based on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." Symptom domain scores range from 0-100, with higher scores reflecting worse status.
Patient's Global Impression of Change (PGIC)	Week 12	Proportion of patients with a PGIC rating of "very much improved" or "much improved" at 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.
Fibromyalgia Impact Questionnaire (FIQR) Revised, Functional Domain Score	Day 1, Week 12	Change from Baseline in the FIQR function domain score at Week 12. The FIQ-R functional domain score is composed of 9 questions which are rated on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." FIQ-R functional domain scores can range from 0-90, with higher scores reflecting worsening status.
Daily Diary Pain	Week -1 (Day -7 to Day -1), Week 12	Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Weekly averages were calculated based on the reported daily scores.
Daily Diary Sleep	Week 12	Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12. Daily sleep quality was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse sleep.
Patient Reported Outcomes Measurement System (PROMIS), Sleep Disturbance	Day 1, Week 12	Change from Baseline in the PROMIS score for sleep disturbance at 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. 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 Reported Outcomes Measurement System (PROMIS), Fatigue	Week 12	Change from Baseline in the PROMIS score for fatigue at Week 12. The Patient-Reported Outcome Measurement Information System (PROMIS) fatigue 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).