A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Tonix Pharmaceuticals, Inc.
- Enrollment
- 514
- Locations
- 1
- Primary Endpoint
- Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.
Study Overview
Brief Summary
This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.
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 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patient is male or female 18 to 65 years of age, inclusive.
- •The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
- •The in clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol defined range.
Exclusion Criteria
- •History of or evidence for a diagnosis of borderline personality disorder (BPD).
Arms & Interventions
TNX-102 SL Tablet, 5.6 mg
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.
Intervention: TNX-102 SL (Drug)
Placebo SL Tablet
1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Intervention: Placebo SL Tablet (Drug)
Outcomes
Primary Outcomes
Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores.
Time Frame: 14 weeks
Patients provide a daily numeric assessment of their average pain (24-hour recall), via an electronic diary, using an 11-point NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Secondary Outcomes
- Change From Baseline to Week 14 in the FIQ-R Function Domain Score(14 weeks)
- Change From Baseline to Week 14 in the PROMIS Score for Fatigue(14 weeks)
- Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved"(14 weeks)
- Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score.(14 weeks)
- Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance(14 weeks)
- Change From Baseline to Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality(14 weeks)