A Phase 2, 14-week Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily at Bedtime in Patients With Multisite Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)
Overview
- Phase
- Phase 2
- Intervention
- TNX-102 SL
- Conditions
- Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
- Sponsor
- Tonix Pharmaceuticals, Inc.
- Enrollment
- 63
- Locations
- 2
- Primary Endpoint
- Daily Diary Pain NRS
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient is male or female, 18 to 65 years of age, inclusive.
- •The patient has a polymerase chain reaction (PCR) confirmed history of SARS-CoV-2 infection at least 3 months prior to enrollment, based on a documented written positive viral test at the time of active infection.
- •The patient has new onset or significant worsening of pain that coincides with a prior COVID-19 infection and has symptoms that have been generally present for at least 3 months but no longer than 18 months.
Exclusion Criteria
- •The patient has been diagnosed with infectious or inflammatory arthritis (eg, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attack within past 2 years is exclusionary), or meets criteria for another type of systemic autoimmune disease (eg, Sjogren's disease).
- •The patient has been diagnosed with a complex regional pain syndrome, fibromyalgia, failed back surgery syndrome, persistent or prevalent pain symptoms related to systemic disease (eg, diabetic peripheral neuropathy, post-herpetic neuropathy), untreated hyperparathyroidism, or a history of prior surgery, trauma, organ or tissue damage, or other source of pain that, in the Investigator's opinion, would confound or interfere with the assessment of the patient's symptoms or require excluded therapies during the patient's study participation.
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
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
Outcomes
Primary Outcomes
Daily Diary Pain NRS
Time Frame: Week 14
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.
Secondary Outcomes
- Daily Diary Sleep Quality NRS(Week 14)
- PROMIS Fatigue -Short Form 8a(Week 14)
- PROMIS Cognitive Function - Abilities-Short Form 8a(Week 14)