Trial · NCT05472090
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, Phase 2, Completed, Tonix Pharmaceuticals, Inc.; results first posted 2024-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT05472090. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05472090
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT05472090
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Conditions
- Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection, COVID-19, Long COVID, Long Haul COVID
- Interventions
- TNX-102 SL, Placebo SL Tablet
- First posted
- 2022-07-25
- Last updated
- 2024-11-26
- Results first posted
- 2024-11-26
- 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.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Daily Diary Pain NRS | 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. |
| Secondary | Daily Diary Sleep Quality NRS | Week 14 | 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. |
| Secondary | PROMIS Fatigue -Short Form 8a | Week 14 | 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. |
| Secondary | PROMIS Cognitive Function - Abilities-Short Form 8a | Week 14 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Daily Diary Pain NRS | Week 14 | Intention-to-treat (ITT) population defined as all patients who were randomized and had at least one post-baseline daily diary entry. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Daily Diary Sleep Quality NRS | Week 14 | Intention-to-treat (ITT) population defined as all patients who were randomized and had at least one post-baseline daily diary entry. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | PROMIS Fatigue -Short Form 8a | Week 14 | Intention-to-treat (ITT) population defined as all patients who were randomized and had at least one post-baseline daily diary entry. | T-score | LEAST_SQUARES_MEAN |
| SECONDARY | PROMIS Cognitive Function - Abilities-Short Form 8a | Week 14 | Intention-to-treat (ITT) population defined as all patients who were randomized and had at least one post-baseline daily diary entry. | T-score | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Daily Diary Pain NRS | TNX-102 SL Tablet, 5.6 mg | -2.2 | Standard Error 0.34 | units on a scale | |
| Daily Diary Pain NRS | Placebo SL Tablet | -2.0 | Standard Error 0.35 | units on a scale | |
| Daily Diary Sleep Quality NRS | TNX-102 SL Tablet, 5.6 mg | -2.1 | Standard Error 0.38 | units on a scale | |
| Daily Diary Sleep Quality NRS | Placebo SL Tablet | -1.6 | Standard Error 0.39 | units on a scale | |
| PROMIS Fatigue -Short Form 8a | TNX-102 SL Tablet, 5.6 mg | -8.0 | Standard Error 1.65 | T-score | |
| PROMIS Fatigue -Short Form 8a | Placebo SL Tablet | -3.2 | Standard Error 1.68 | T-score | |
| PROMIS Cognitive Function - Abilities-Short Form 8a | TNX-102 SL Tablet, 5.6 mg | 5.4 | Standard Error 1.55 | T-score | |
| PROMIS Cognitive Function - Abilities-Short Form 8a | Placebo SL Tablet | 3.5 | Standard Error 1.55 | T-score |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TNX-102 SL Tablet, 5.6 mg | 32 | |
| Overall Study | STARTED | Placebo SL Tablet | 31 | |
| Overall Study | COMPLETED | TNX-102 SL Tablet, 5.6 mg | 26 | |
| Overall Study | COMPLETED | Placebo SL Tablet | 25 | |
| Overall Study | NOT COMPLETED | TNX-102 SL Tablet, 5.6 mg | 6 | |
| Overall Study | NOT COMPLETED | Placebo SL Tablet | 6 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypoaesthesia oral | Gastrointestinal disorders | TNX-102 SL Tablet, 5.6 mg | 6 | 32 | |
| other | Hypoaesthesia oral | Gastrointestinal disorders | Placebo SL Tablet | 0 | 31 | |
| other | Glossodynia | Gastrointestinal disorders | TNX-102 SL Tablet, 5.6 mg | 2 | 32 | |
| other | Glossodynia | Gastrointestinal disorders | Placebo SL Tablet | 0 | 31 | |
| other | Oral Pain | Gastrointestinal disorders | TNX-102 SL Tablet, 5.6 mg | 2 | 32 | |
| other | Oral Pain | Gastrointestinal disorders | Placebo SL Tablet | 0 | 31 | |
| other | Paraesthesia oral | Gastrointestinal disorders | TNX-102 SL Tablet, 5.6 mg | 2 | 32 | |
| other | Paraesthesia oral | Gastrointestinal disorders | Placebo SL Tablet | 0 | 31 | |
| other | Influenza like illness | General disorders | TNX-102 SL Tablet, 5.6 mg | 0 | 32 | |
| other | Influenza like illness | General disorders | Placebo SL Tablet | 2 | 31 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TNX-102 SL Tablet, 5.6 mg | 0 | 32 |
| Total, all-cause mortality | Placebo SL Tablet | 0 | 31 |
| Total, other adverse events | TNX-102 SL Tablet, 5.6 mg | 12 | 32 |
| Total, other adverse events | Placebo SL Tablet | 2 | 31 |
| Total, serious adverse events | TNX-102 SL Tablet, 5.6 mg | 0 | 32 |
| Total, serious adverse events | Placebo SL Tablet | 0 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TNX-102 SL Tablet, 5.6 mg vs Placebo SL Tablet: deaths from any cause | Trial comparisons |
| TNX-102 SL Tablet, 5.6 mg vs Placebo SL Tablet: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05472090
GET https://conductscience.org/api/trials/v1/NCT05472090/registered