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

COVID-19 Clinical Trial

— PREVAIL  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05472090
• Other study ID #: TNX-CY-PA201
• Status: Completed
• Phase: Phase 2
• Start date: August 18, 2022
• Est. completion date: July 27, 2023

Study information

• Verified date: September 2023
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 27, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Long 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.
• 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.

Locations

Country	Name	City	State
United States	Tonix Clinical Site	Albuquerque	New Mexico
United States	Tonix Clinical Site	Alpharetta	Georgia
United States	Tonix Clinical Site	Atlanta	Georgia
United States	Tonix Clinical Site	Austin	Texas
United States	Tonix Clinical Site	Aventura	Florida
United States	Accel Research-Birmingham Clinical Research Unit	Birmingham	Alabama
United States	Tonix Clinical Site	Boston	Massachusetts
United States	Tonix Clinical Site	Boston	Massachusetts
United States	Tonix Clinical Site	Centennial	Colorado
United States	Tonix Clinical Site	Chicago	Illinois
United States	Tonix Clinical Site	Columbus	Ohio
United States	Tonix Clinical Site	Dayton	Ohio
United States	Tonix Clinical Site	Des Moines	Iowa
United States	Tonix Clinical Site	Fort Myers	Florida
United States	Tonix Clinical Site	Gulfport	Mississippi
United States	Tonix Clinical Site	Iowa City	Iowa
United States	Tonix Clinical Site	McKinney	Texas
United States	Tonix Clinical Site	Methuen	Massachusetts
United States	Tonix Clinical Site	New Orleans	Louisiana
United States	Tonix Clinical Site	New York	New York
United States	Tonix Clinical Site	Oceanside	California
United States	Tonix Clinical Site	Orlando	Florida
United States	Tonix Clinical Site	Prairie Village	Kansas
United States	Tonix Clinical Site	Prairieville	Louisiana
United States	Tonix Clinical Site	Saint Petersburg	Florida
United States	Tonix Clinical Site	Santa Ana	California
United States	Tonix Clinical Site	Shelby	North Carolina
United States	Tonix Clinical Site	Tulsa	Oklahoma
United States	Tonix Clinical Site	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Pain Score	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.	Week 14
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance	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.	Week 14