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
Overview
- Phase
- Phase 3
- Intervention
- TNX-102 SL Tablet, 2.8mg
- Conditions
- Fibromyalgia
- Sponsor
- Tonix Pharmaceuticals, Inc.
- Enrollment
- 519
- Primary Endpoint
- Proportion of Patients With ≥30% Pain Improvement
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.
The present trial is 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
- •Male or female 18-75 years old
- •For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressant 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-out specific medications (ask PI)
- •Known hypersensitivity to cyclobenzaprine
- •Others: seizure disorders, severe/untreated sleep apnea, BMI\>40
Arms & Interventions
TNX-102 SL Tablet, 2.8 mg
1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
Intervention: TNX-102 SL Tablet, 2.8mg
Placebo SL Tablet
1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks
Intervention: Placebo SL Tablet
Outcomes
Primary Outcomes
Proportion of Patients With ≥30% Pain Improvement
Time Frame: Day 1, Week 12
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement (responder criteria) from baseline to Week 12 in the weekly mean of the daily self-reported 24-hour recall average pain intensity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Secondary Outcomes
- Patient's Global Impression of Change (PGIC)(Week 12)
- Change From Baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score(Day 1, Week 12)
- Change From Baseline to Week 12 in the FIQR Function Domain Score(Day 1, Week 12)
- Patient Reported Outcomes Measurement System (PROMIS) Sleep Disturbance(Day 1, Week 12)
- Weekly Average of Daily Sleep Quality Diary(Baseline (Day -7 to Day -1), Week 12)
- Patient Reported Outcomes Measurement System (PROMIS) Fatigue(Day 1, Week 12)
- Weekly Average of Daily Pain Diary(Baseline (Day -7 to Day -1), Week 12)