This is a Phase 2, 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 once daily at bedtime for the management of multi-site pain associated with Long COVID.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
63
Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
Accel Research-Birmingham Clinical Research Unit
Birmingham, Alabama, United States
Tonix Clinical Site
Oceanside, California, United States
Tonix Clinical Site
Santa Ana, California, United States
Tonix Clinical Site
Centennial, Colorado, United States
Tonix Clinical Site
Aventura, Florida, United States
Tonix Clinical Site
Fort Myers, Florida, United States
Tonix Clinical Site
Orlando, Florida, United States
Tonix Clinical Site
St. Petersburg, Florida, United States
Tonix Clinical Site
Alpharetta, Georgia, United States
Tonix Clinical Site
Atlanta, Georgia, United States
...and 19 more locations
Daily Diary Pain NRS
Change from Baseline in the diary Numeric Rating Scale (NRS) weekly average of daily self-reported worst Long COVID pain intensity scores at the Week 14 endpoint. Scores range from 0 to 10 where a higher score means worse outcome.
Time frame: Week 14
Daily Diary Sleep Quality NRS
Mean change from baseline in the weekly average of the daily diary numeric rating scale (NRS) assessment of sleep quality at the Week 14 endpoint. Scores range from 0 to 10 where a higher score means worse outcome.
Time frame: Week 14
PROMIS Fatigue -Short Form 8a
Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue at the Week 14 endpoint. Subjects are asked to reflect on their fatigue symptoms in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.
Time frame: Week 14
PROMIS Cognitive Function - Abilities-Short Form 8a
Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for cognitive function at the Week 14 endpoint. Subjects are asked to reflect on their cognitive function and abilities in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10.
Time frame: Week 14
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