Trial · NCT04172831

A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

NCT04172831, Phase 3, Completed, Tonix Pharmaceuticals, Inc.; results first posted 2022-08-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia. Trials, record NCT04172831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04172831

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
NCT number: NCT04172831
Status: Completed
Phases: Phase 3
Enrollment: 503 participants, actual
Lead sponsor: Tonix Pharmaceuticals, Inc.
Conditions: Fibromyalgia
Interventions: TNX-102 SL, Placebo SL Tablet
First posted: 2019-11-21
Last updated: 2022-08-08
Results first posted: 2022-08-08
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 (FIQR) 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 FIQR Function Domain Score	14 weeks	The FIQ-R is a validated questionnaire. Scores 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 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 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 patient 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 patient 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 (FIQR) 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 FIQR 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	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 Tablets, 5.6 mg	-1.9	95% Confidence Interval -2.1 to -1.7	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	-1.5	95% Confidence Interval -1.7 to -1.3	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 Tablets, 5.6 mg	93		Participants
Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of Very Much Improved or Much Improved	Placebo SL Tablet	75		Participants
Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score	TNX-102 SL Tablets, 5.6 mg	-18.4	95% Confidence Interval -20.8 to -16.0	score on a scale
Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score	Placebo SL Tablet	-14.0	95% Confidence Interval -16.4 to -11.7	score on a scale
Change From Baseline to Week 14 in the FIQR Function Domain Score	TNX-102 SL Tablets, 5.6 mg	-13.6	95% Confidence Interval -16.1 to -11.2	score on a scale
Change From Baseline to Week 14 in the FIQR Function Domain Score	Placebo SL Tablet	-9.3	95% Confidence Interval -11.7 to -6.8	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 Tablets, 5.6 mg	-9.5	95% Confidence Interval -10.7 to -8.2	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	-6.5	95% Confidence Interval -7.7 to -5.4	score on a scale

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	TNX-102 SL Tablets, 5.6 mg	248
Overall Study	STARTED	Placebo SL Tablet	255
Overall Study	COMPLETED	TNX-102 SL Tablets, 5.6 mg	204
Overall Study	COMPLETED	Placebo SL Tablet	213
Overall Study	NOT COMPLETED	TNX-102 SL Tablets, 5.6 mg	44
Overall Study	NOT COMPLETED	Placebo SL Tablet	42

Source ClinicalTrials.gov

Adverse events34

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
other	Hypoaesthesia oral	Gastrointestinal disorders	TNX-102 SL Tablets, 5.6 mg	43	248
other	Hypoaesthesia oral	Gastrointestinal disorders	Placebo SL Tablet	1	255
other	Paraesthesia oral	Gastrointestinal disorders	TNX-102 SL Tablets, 5.6 mg	14	248
other	Paraesthesia oral	Gastrointestinal disorders	Placebo SL Tablet	1	255
other	Dysguesia	Nervous system disorders	TNX-102 SL Tablets, 5.6 mg	13	248
other	Dysguesia	Nervous system disorders	Placebo SL Tablet	1	255
serious	Spinal compression fracture	Injury, poisoning and procedural complications	TNX-102 SL Tablets, 5.6 mg	1	248
serious	Spinal compression fracture	Injury, poisoning and procedural complications	Placebo SL Tablet	0	255
serious	Pneumonia	Infections and infestations	TNX-102 SL Tablets, 5.6 mg	1	248
serious	Pneumonia	Infections and infestations	Placebo SL Tablet	0	255

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TNX-102 SL Tablets, 5.6 mg	0	248
Total, all-cause mortality	Placebo SL Tablet	0	255
Total, other adverse events	TNX-102 SL Tablets, 5.6 mg	70	248
Total, other adverse events	Placebo SL Tablet	3	255
Total, serious adverse events	TNX-102 SL Tablets, 5.6 mg	2	248
Total, serious adverse events	Placebo SL Tablet	5	255

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37165930	DERIVED

Source PubMed

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 Tablets, 5.6 mg vs Placebo SL Tablet: deaths from any cause	Trial comparisons
TNX-102 SL Tablets, 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 Tablets, 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04172831

GET https://conductscience.org/api/trials/v1/NCT04172831/events?page=2

API reference For AI assistants