A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection (PREVAIL)

• ClinicalTrials.gov Identifier: NCT05472090
• Recruitment Status: Completed
• First Posted: July 25, 2022
• Last Update Posted: September 6, 2023
• Sponsor: Tonix Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Tonix Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: July 21, 2022
• First Posted Date: July 25, 2022
• Last Update Posted Date: September 6, 2023
• Actual Study Start Date: August 18, 2022
• Actual Primary Completion Date: July 12, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 26, 2022)

Mean Pain Score [ 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.

Original Primary Outcome Measures (submitted: July 21, 2022)

Mean Pain Score [ Time Frame: Week 14 ]

Change from Baseline in the diary NRS weekly average of daily self-reported worst Long COVID pain intensity scores at the Week 14 endpoint

Current Secondary Outcome Measures (submitted: July 26, 2022)

Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance [ Time Frame: Week 14 ]

Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance at the Week 14 endpoint. This form consists of 8 items in a 1-5 Likert scale. A higher score means a worse outcome.

Original Secondary Outcome Measures (submitted: July 21, 2022)

PROMIS score for sleep disturbance [ Time Frame: Week 14 ]

Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance at the Week 14 endpoint

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection
• Official Title: 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
• COVID-19
• Long COVID
• Long Haul COVID

Intervention

• Drug: TNX-102 SL
  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.
• Drug: Placebo SL Tablet
  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.

Study Arms

• Experimental: 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: Drug: TNX-102 SL
• Placebo Comparator: 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: Drug: Placebo SL Tablet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 5, 2023): 63
• Original Estimated Enrollment (submitted: July 21, 2022): 470
• Actual Study Completion Date: July 27, 2023
• Actual Primary Completion Date: July 12, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Major 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.

Major 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05472090
• Other Study ID Numbers: TNX-CY-PA201
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Tonix Pharmaceuticals, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Tonix Pharmaceuticals, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Herb Harris, MD, PhD; Tonix Pharmaceuticals

• PRS Account: Tonix Pharmaceuticals, Inc.
• Verification Date: September 2023