A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The EFFIcacy and Safety of TNX-102 SL Tablets Taken Daily At Bedtime In Patients With FibRoMyalgia
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Tonix Pharmaceuticals, Inc.
- Enrollment
- 51
- Primary Endpoint
- Weekly Mean Pain Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: TNX-102 SL Tablet, 2.8 mg (Drug)
Placebo SL Tablet
1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks
Intervention: Placebo SL Tablet (Drug)
Outcomes
Primary Outcomes
Weekly Mean Pain Score
Time Frame: 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 Outcomes
- Fibromyalgia Impact Questionnaire (FIQR) Revised, Symptoms Domain(Day 1, Week 12)
- Patient's Global Impression of Change (PGIC)(Week 12)
- Fibromyalgia Impact Questionnaire (FIQR) Revised, Functional Domain Score(Day 1, Week 12)
- Daily Diary Pain(Week -1 (Day -7 to Day -1), Week 12)
- Daily Diary Sleep(Week 12)
- Patient Reported Outcomes Measurement System (PROMIS), Sleep Disturbance(Day 1, Week 12)
- Patient Reported Outcomes Measurement System (PROMIS), Fatigue(Week 12)