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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Diary Sleep Quality NRS | Mean change from baseline in the weekly average of the daily diary numeric rating scale (NRS) assessment of sleep quality at the Week 14 endpoint. Scores range from 0 to 10 where a higher score means worse outcome. | Week 14 |
| PROMIS Fatigue -Short Form 8a |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herb Harris, MD, PhD | Tonix Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accel Research-Birmingham Clinical Research Unit | Birmingham | Alabama | 35216 | United States | ||
| Tonix Clinical Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 13, 2022 | Oct 15, 2024 |
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| 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. |
|
Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue at the Week 14 endpoint. Subjects are asked to reflect on their fatigue symptoms in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. |
| Week 14 |
| PROMIS Cognitive Function - Abilities-Short Form 8a | Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for cognitive function at the Week 14 endpoint. Subjects are asked to reflect on their cognitive function and abilities in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. | Week 14 |
| Oceanside |
| California |
| 92056 |
| United States |
| Tonix Clinical Site | Santa Ana | California | 92705 | United States |
| Tonix Clinical Site | Centennial | Colorado | 80112 | United States |
| Tonix Clinical Site | Aventura | Florida | 33180 | United States |
| Tonix Clinical Site | Fort Myers | Florida | 33912 | United States |
| Tonix Clinical Site | Orlando | Florida | 32801 | United States |
| Tonix Clinical Site | St. Petersburg | Florida | 33709 | United States |
| Tonix Clinical Site | Alpharetta | Georgia | 30022 | United States |
| Tonix Clinical Site | Atlanta | Georgia | 30329 | United States |
| Tonix Clinical Site | Chicago | Illinois | 60625 | United States |
| Tonix Clinical Site | Des Moines | Iowa | 50265 | United States |
| Tonix Clinical Site | Iowa City | Iowa | 52242 | United States |
| Tonix Clinical Site | Prairie Village | Kansas | 66208 | United States |
| Tonix Clinical Site | New Orleans | Louisiana | 70124 | United States |
| Tonix Clinical Site | Prairieville | Louisiana | 70769 | United States |
| Tonix Clinical Site | Boston | Massachusetts | 02115 | United States |
| Tonix Clinical Site | Boston | Massachusetts | 02131 | United States |
| Tonix Clinical Site | Methuen | Massachusetts | 01844 | United States |
| Tonix Clinical Site | Gulfport | Mississippi | 39503 | United States |
| Tonix Clinical Site | Albuquerque | New Mexico | 87109 | United States |
| Tonix Clinical Site | New York | New York | 10036 | United States |
| Tonix Clinical Site | Williamsville | New York | 14221 | United States |
| Tonix Clinical Site | Shelby | North Carolina | 28150 | United States |
| Tonix Clinical Site | Columbus | Ohio | 43215 | United States |
| Tonix Clinical Site | Dayton | Ohio | 45432 | United States |
| Tonix Clinical Site | Tulsa | Oklahoma | 74133 | United States |
| Tonix Clinical Site | Austin | Texas | 78737 | United States |
| Tonix Clinical Site | McKinney | Texas | 75070 | United States |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention-to-treat (ITT) population defined as all patients who were randomized and had at least one post-baseline daily diary entry. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 14 |
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| Secondary | Daily Diary Sleep Quality NRS | Mean change from baseline in the weekly average of the daily diary numeric rating scale (NRS) assessment of sleep quality at the Week 14 endpoint. Scores range from 0 to 10 where a higher score means worse outcome. | Intention-to-treat (ITT) population defined as all patients who were randomized and had at least one post-baseline daily diary entry. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 14 |
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| Secondary | PROMIS Fatigue -Short Form 8a | Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue at the Week 14 endpoint. Subjects are asked to reflect on their fatigue symptoms in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. | Intention-to-treat (ITT) population defined as all patients who were randomized and had at least one post-baseline daily diary entry. | Posted | Least Squares Mean | Standard Error | T-score | Week 14 |
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| Secondary | PROMIS Cognitive Function - Abilities-Short Form 8a | Change from Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) score for cognitive function at the Week 14 endpoint. Subjects are asked to reflect on their cognitive function and abilities in the past 7 days and respond to 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. | Intention-to-treat (ITT) population defined as all patients who were randomized and had at least one post-baseline daily diary entry. | Posted | Least Squares Mean | Standard Error | T-score | Week 14 |
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Patients were monitored for AEs throughout the study. The total duration of the study, including screening and follow up, was as long as 25 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 32 | 0 | 32 | 12 | 32 |
| EG001 | 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. | 0 | 31 | 0 | 31 | 2 | 31 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment | Tongue numbness |
|
| Glossodynia | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment | burning tongue/sensation of the tongue, tongue discomfort |
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| Oral Pain | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 24.1 | Systematic Assessment |
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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.
An industry standard NDA is in place with all study investigators.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory Sullivan, MD | Tonix Pharmaceuticals | (862) 799-8599 | greg.sullivan@tonixpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2023 | Oct 15, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D000086382 | COVID-19 |
| D000094024 | Post-Acute COVID-19 Syndrome |
| D020447 | Parasomnias |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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