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
NCT ID: NCT05472090
Last Updated: 2024-11-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2022-08-18
2023-07-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia
NCT02829814
Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults
NCT01889173
Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults
NCT01689259
Impact of Colchicine and Low-dose Naltrexone on COVID-19
NCT04756128
RN624 In Adult Patients With Chronic Low Back Pain
NCT00584870
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tonix Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Herb Harris, MD, PhD
Role: STUDY_DIRECTOR
Tonix Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Tonix Clinical Site
Chicago, Illinois, United States
Tonix Clinical Site
Des Moines, Iowa, United States
Tonix Clinical Site
Iowa City, Iowa, United States
Tonix Clinical Site
Prairie Village, Kansas, United States
Tonix Clinical Site
New Orleans, Louisiana, United States
Tonix Clinical Site
Prairieville, Louisiana, United States
Tonix Clinical Site
Boston, Massachusetts, United States
Tonix Clinical Site
Boston, Massachusetts, United States
Tonix Clinical Site
Methuen, Massachusetts, United States
Tonix Clinical Site
Gulfport, Mississippi, United States
Tonix Clinical Site
Albuquerque, New Mexico, United States
Tonix Clinical Site
New York, New York, United States
Tonix Clinical Site
Williamsville, New York, United States
Tonix Clinical Site
Shelby, North Carolina, United States
Tonix Clinical Site
Columbus, Ohio, United States
Tonix Clinical Site
Dayton, Ohio, United States
Tonix Clinical Site
Tulsa, Oklahoma, United States
Tonix Clinical Site
Austin, Texas, United States
Tonix Clinical Site
McKinney, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TNX-CY-PA201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.