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

NCT05472090 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TNX-CY-PA201
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 29

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.

Conditions

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

Keywords

Multi-site pain; Sleep disturbance; PASC; COVID-19; Long COVID; Coronavirus infections

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 14

Secondary Outcomes (3)

• Daily Diary Sleep Quality NRS

  Week 14

• PROMIS Fatigue -Short Form 8a

  Week 14

• PROMIS Cognitive Function - Abilities-Short Form 8a

  Week 14

Study Arms (2)

TNX-102 SL Tablet, 5.6 mg

EXPERIMENTAL

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.

Drug: TNX-102 SL

Placebo SL Tablet

PLACEBO COMPARATOR

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.

Drug: Placebo SL Tablet

Interventions

TNX-102 SL DRUG

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.

TNX-102 SL Tablet, 5.6 mg

Placebo SL Tablet DRUG

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead

Study Sites (29)

Accel Research-Birmingham Clinical Research Unit

Birmingham, Alabama, 35216, United States

Location

Tonix Clinical Site

Oceanside, California, 92056, United States

Location

Tonix Clinical Site

Santa Ana, California, 92705, United States

Location

Tonix Clinical Site

Centennial, Colorado, 80112, United States

Location

Tonix Clinical Site

Aventura, Florida, 33180, United States

Location

Tonix Clinical Site

Fort Myers, Florida, 33912, United States

Location

Tonix Clinical Site

Orlando, Florida, 32801, United States

Location

Tonix Clinical Site

St. Petersburg, Florida, 33709, United States

Location

Tonix Clinical Site

Alpharetta, Georgia, 30022, United States

Location

Tonix Clinical Site

Atlanta, Georgia, 30329, United States

Location

Tonix Clinical Site

Chicago, Illinois, 60625, United States

Location

Tonix Clinical Site

Des Moines, Iowa, 50265, United States

Location

Tonix Clinical Site

Iowa City, Iowa, 52242, United States

Location

Tonix Clinical Site

Prairie Village, Kansas, 66208, United States

Location

Tonix Clinical Site

New Orleans, Louisiana, 70124, United States

Location

Tonix Clinical Site

Prairieville, Louisiana, 70769, United States

Location

Tonix Clinical Site

Boston, Massachusetts, 02115, United States

Location

Tonix Clinical Site

Boston, Massachusetts, 02131, United States

Location

Tonix Clinical Site

Methuen, Massachusetts, 01844, United States

Location

Tonix Clinical Site

Gulfport, Mississippi, 39503, United States

Location

Tonix Clinical Site

Albuquerque, New Mexico, 87109, United States

Location

Tonix Clinical Site

New York, New York, 10036, United States

Location

Tonix Clinical Site

Williamsville, New York, 14221, United States

Location

Tonix Clinical Site

Shelby, North Carolina, 28150, United States

Location

Tonix Clinical Site

Columbus, Ohio, 43215, United States

Location

Tonix Clinical Site

Dayton, Ohio, 45432, United States

Location

Tonix Clinical Site

Tulsa, Oklahoma, 74133, United States

Location

Tonix Clinical Site

Austin, Texas, 78737, United States

Location

Tonix Clinical Site

McKinney, Texas, 75070, United States

Location

MeSH Terms

Conditions

Infections; COVID-19; Post-Acute COVID-19 Syndrome; Parasomnias; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Limitations and Caveats

We consider the study completed and not terminated because although participant enrollment stopped early, those that were already enrolled in the study were allowed to complete treatment and all assessments and visits per protocol. Therefore, we consider that participant's last visit has occurred.

Results Point of Contact

• Title: Gregory Sullivan, MD
• Organization: Tonix Pharmaceuticals

greg.sullivan@tonixpharma.com

(862) 799-8599

Study Officials

• Herb Harris, MD, PhD

  Tonix Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: August 18, 2022
• Primary Completion: July 12, 2023
• Study Completion: July 27, 2023
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)