Trial · NCT04508621
A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
NCT04508621, Phase 3, Completed, Tonix Pharmaceuticals, Inc.; results first posted 2022-12-02
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia. Trials, record NCT04508621. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04508621
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
- NCT number
- NCT04508621
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 514 participants, actual
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Conditions
- Fibromyalgia
- Interventions
- TNX-102 SL, Placebo SL Tablet
- First posted
- 2020-08-11
- Last updated
- 2023-12-18
- Results first posted
- 2022-12-02
- Limitations and caveats
- Recruitment during COVID-19 pandemic
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores. | 14 weeks | Patients provide a daily numeric assessment of their average pain (24-hour recall), via an electronic diary, using an 11-point NRS. Scores range from 0 (no pain) to 10 (worst possible pain). |
| Secondary | Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved" | 14 weeks | The PGIC is a fibromyalgia specific validated instrument on a scale of 1 to 7, where a score of 1 indicates the highest level of improvement and a score of 7 indicates a much worse outcome. |
| Secondary | Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score. | 14 weeks | The FIQ-R is a validated questionnaire. Scores on the symptoms domain range from 0 to 100 where a higher score means worse outcome. |
| Secondary | Change From Baseline to Week 14 in the FIQ-R Function Domain Score | 14 weeks | The FIQ-R is a validated questionnaire. Score on the function domain range from 0 to 90 where a higher score means worse outcome. |
| Secondary | Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance | 14 weeks | The PROMIS Sleep disturbance short form 8a consists of 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. |
| Secondary | Change From Baseline to Week 14 in the PROMIS Score for Fatigue | 14 weeks | The PROMIS fatigue short form 8a consist of 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. |
| Secondary | Change From Baseline to Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality | 14 weeks | Patients provide a daily numeric assessment of their sleep quality for the previous night, via an electronic diary, using an 11-point NRS. Scores range from 0 (best possible sleep) to 10 (worst possible sleep). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores. | 14 weeks | Intent to treat population (all patients who were randomized). Multiple imputation for missing data. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of Very Much Improved or Much Improved | 14 weeks | Intent to Treat population (all patients who were randomized). Patients with missing data as non-responders. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score. | 14 weeks | Intent to Treat population (all patients who were randomized). Multiple imputation for missing data. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 14 in the FIQ-R Function Domain Score | 14 weeks | Intent to Treat population (all patients who were randomized). Multiple imputation for missing data. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance | 14 weeks | Intent to Treat population (all patients who were randomized). Multiple imputation for missing data. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 14 in the PROMIS Score for Fatigue | 14 weeks | Intent to Treat population (all patients who were randomized). Multiple imputation for missing data. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality | 14 weeks | Intent to Treat population (all patients who were randomized). Multiple imputation for missing data. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores. | TNX-102 SL Tablet, 5.6 mg | -1.6 | 95% Confidence Interval -1.8 to -1.3 | score on a scale | |
| Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores. | Placebo SL Tablet | -1.3 | 95% Confidence Interval -1.5 to -1.1 | score on a scale | |
| Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of Very Much Improved or Much Improved | TNX-102 SL Tablet, 5.6 mg | 76 | Participants | ||
| Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of Very Much Improved or Much Improved | Placebo SL Tablet | 56 | Participants | ||
| Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score. | TNX-102 SL Tablet, 5.6 mg | -15.3 | 95% Confidence Interval -17.6 to -13.1 | score on a scale | |
| Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score. | Placebo SL Tablet | -12.0 | 95% Confidence Interval -14.2 to -9.8 | score on a scale | |
| Change From Baseline to Week 14 in the FIQ-R Function Domain Score | TNX-102 SL Tablet, 5.6 mg | -8.8 | 95% Confidence Interval -10.9 to -6.7 | score on a scale | |
| Change From Baseline to Week 14 in the FIQ-R Function Domain Score | Placebo SL Tablet | -8.4 | 95% Confidence Interval -10.5 to -6.4 | score on a scale | |
| Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance | TNX-102 SL Tablet, 5.6 mg | -7.4 | 95% Confidence Interval -8.6 to -6.2 | score on a scale | |
| Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance | Placebo SL Tablet | -5.1 | 95% Confidence Interval -6.2 to -4.0 | score on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant 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 | 256 | |
| Overall Study | STARTED | Placebo SL Tablet | 258 | |
| Overall Study | COMPLETED | TNX-102 SL Tablet, 5.6 mg | 189 | |
| Overall Study | COMPLETED | Placebo SL Tablet | 210 | |
| Overall Study | NOT COMPLETED | TNX-102 SL Tablet, 5.6 mg | 67 | |
| Overall Study | NOT COMPLETED | Placebo SL Tablet | 48 |
Source ClinicalTrials.gov
Adverse events22
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 | 72 | 256 | |
| other | Hypoaesthesia oral | Gastrointestinal disorders | Placebo SL Tablet | 2 | 258 | |
| other | Oral discomfort | Gastrointestinal disorders | TNX-102 SL Tablet, 5.6 mg | 23 | 256 | |
| other | Oral discomfort | Gastrointestinal disorders | Placebo SL Tablet | 2 | 258 | |
| other | Tongue discomfort | Gastrointestinal disorders | TNX-102 SL Tablet, 5.6 mg | 16 | 256 | |
| other | Tongue discomfort | Gastrointestinal disorders | Placebo SL Tablet | 2 | 258 | |
| other | Product taste abnormal | Product Issues | TNX-102 SL Tablet, 5.6 mg | 26 | 256 | |
| other | Product taste abnormal | Product Issues | Placebo SL Tablet | 2 | 258 | |
| serious | COVID-19 pneumonia | Infections and infestations | TNX-102 SL Tablet, 5.6 mg | 1 | 256 | |
| serious | COVID-19 pneumonia | Infections and infestations | Placebo SL Tablet | 0 | 258 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse 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 | 256 |
| Total, all-cause mortality | Placebo SL Tablet | 0 | 258 |
| Total, other adverse events | TNX-102 SL Tablet, 5.6 mg | 80 | 256 |
| Total, other adverse events | Placebo SL Tablet | 5 | 258 |
| Total, serious adverse events | TNX-102 SL Tablet, 5.6 mg | 6 | 256 |
| Total, serious adverse events | Placebo SL Tablet | 0 | 258 |
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 comparisons3
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: Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of Very Much Improved or Much Improved | 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/NCT04508621
GET https://conductscience.org/api/trials/v1/NCT04508621/events?page=2