Trial · NCT02436096

A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

NCT02436096, Phase 3, Completed, Tonix Pharmaceuticals, Inc.; results first posted 2025-02-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia. Trials, record NCT02436096. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02436096

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Trial

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

Title: A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia
NCT number: NCT02436096
Status: Completed
Phases: Phase 3
Enrollment: 519 participants, actual
Lead sponsor: Tonix Pharmaceuticals, Inc.
Conditions: Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Musculoskeletal Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic Diseases
Interventions: TNX-102 SL Tablet, 2.8mg, Placebo SL Tablet
First posted: 2015-05-06
Last updated: 2025-02-07
Results first posted: 2025-02-07

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Patients With ≥30% Pain Improvement	Day 1, Week 12	The primary efficacy endpoint is the proportion of patients with a ≥30% improvement (responder criteria) from baseline to Week 12 in the weekly mean of the daily self-reported 24-hour recall average pain intensity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain).
Secondary	Patient's Global Impression of Change (PGIC)	Week 12	Proportion of patients with a PGIC rating of 1 ("very much improved") or 2 ("much improved") at Week 12. 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 the highest level of worsening.
Secondary	Change From Baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score	Day 1, Week 12	The FIQR 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 12 in the FIQR Function Domain Score	Day 1, Week 12	The FIQR is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome.
Secondary	Patient Reported Outcomes Measurement System (PROMIS) Sleep Disturbance	Day 1, Week 12	Change from baseline in the PROMIS score for sleep disturbance at Week 12. 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. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. Lower T-scores indicate less sleep disturbance.
Secondary	Weekly Average of Daily Sleep Quality Diary	Baseline (Day -7 to Day -1), Week 12	Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12. 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).
Secondary	Patient Reported Outcomes Measurement System (PROMIS) Fatigue	Day 1, Week 12	Change from Baseline in the PROMIS score for fatigue at Week 12. 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. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. Lower T-scores indicate less fatigue.
Secondary	Weekly Average of Daily Pain Diary	Baseline (Day -7 to Day -1), Week 12	Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain).

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Patients With ≥30% Pain Improvement	Day 1, Week 12	Results are reported for the ITT population which includes all patients who were randomized.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Patient's Global Impression of Change (PGIC)	Week 12	Results are reported for the ITT population which includes all patients who were randomized.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score	Day 1, Week 12	Results are reported for the ITT population which includes all patients who were randomized.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 12 in the FIQR Function Domain Score	Day 1, Week 12	Results are reported for the ITT population which includes all patients who were randomized.	units on a scale	MEAN
SECONDARY	Patient Reported Outcomes Measurement System (PROMIS) Sleep Disturbance	Day 1, Week 12	Results are reported for the ITT population which includes all patients who were randomized.	T-score	LEAST_SQUARES_MEAN
SECONDARY	Weekly Average of Daily Sleep Quality Diary	Baseline (Day -7 to Day -1), Week 12	Results are reported for the ITT population which includes all patients who were randomized.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Patient Reported Outcomes Measurement System (PROMIS) Fatigue	Day 1, Week 12	Results are reported for the ITT population which includes all patients who were randomized.	T-score	LEAST_SQUARES_MEAN
SECONDARY	Weekly Average of Daily Pain Diary	Baseline (Day -7 to Day -1), Week 12	Results are reported for the ITT population which includes all patients who were randomized.	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Proportion of Patients With ≥30% Pain Improvement	Placebo SL Tablet	58		Participants
Proportion of Patients With ≥30% Pain Improvement	TNX-102 SL Tablet, 2.8 mg	75		Participants
Patient's Global Impression of Change (PGIC)	Placebo SL Tablet	42		Participants
Patient's Global Impression of Change (PGIC)	TNX-102 SL Tablet, 2.8 mg	62		Participants
Change From Baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score	Placebo SL Tablet	-8.2	Standard Error 1.13	units on a scale
Change From Baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score	TNX-102 SL Tablet, 2.8 mg	-14.1	Standard Error 1.14	units on a scale
Change From Baseline to Week 12 in the FIQR Function Domain Score	Placebo SL Tablet	-4.4	Standard Error 1.15	units on a scale
Change From Baseline to Week 12 in the FIQR Function Domain Score	TNX-102 SL Tablet, 2.8 mg	-10.3	Standard Error 1.16	units on a scale
Patient Reported Outcomes Measurement System (PROMIS) Sleep Disturbance	Placebo SL Tablet	-4.7	Standard Error .53	T-score
Patient Reported Outcomes Measurement System (PROMIS) Sleep Disturbance	TNX-102 SL Tablet, 2.8 mg	-8.0	Standard Error .54	T-score

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo SL Tablet	257
Overall Study	STARTED	TNX-102 SL Tablet, 2.8 mg	262
Overall Study	COMPLETED	Placebo SL Tablet	222
Overall Study	COMPLETED	TNX-102 SL Tablet, 2.8 mg	203
Overall Study	NOT COMPLETED	Placebo SL Tablet	35
Overall Study	NOT COMPLETED	TNX-102 SL Tablet, 2.8 mg	59

Source ClinicalTrials.gov

Adverse events26

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	Placebo SL Tablet	2	256
other	Hypoaesthesia Oral	Gastrointestinal disorders	TNX-102 SL Tablet, 2.8 mg	105	262
other	Glossodynia	Gastrointestinal disorders	Placebo SL Tablet	4	256
other	Glossodynia	Gastrointestinal disorders	TNX-102 SL Tablet, 2.8 mg	24	262
other	Paraesthesia Oral	Gastrointestinal disorders	Placebo SL Tablet	3	256
other	Paraesthesia Oral	Gastrointestinal disorders	TNX-102 SL Tablet, 2.8 mg	20	262
other	Product Taste Abnormal	Product Issues	Placebo SL Tablet	2	256
other	Product Taste Abnormal	Product Issues	TNX-102 SL Tablet, 2.8 mg	16	262
other	Fatigue	General disorders	Placebo SL Tablet	6	256
other	Fatigue	General disorders	TNX-102 SL Tablet, 2.8 mg	15	262

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo SL Tablet	0	256
Total, all-cause mortality	TNX-102 SL Tablet, 2.8 mg	0	262
Total, other adverse events	Placebo SL Tablet	17	256
Total, other adverse events	TNX-102 SL Tablet, 2.8 mg	132	262
Total, serious adverse events	Placebo SL Tablet	4	256
Total, serious adverse events	TNX-102 SL Tablet, 2.8 mg	3	262

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 comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
TNX-102 SL Tablet, 2.8 mg vs Placebo SL Tablet: Proportion of Patients With ≥30% Pain Improvement	Trial comparisons
TNX-102 SL Tablet, 2.8 mg vs Placebo SL Tablet: Patient's Global Impression of Change (PGIC)	Trial comparisons
TNX-102 SL Tablet, 2.8 mg vs Placebo SL Tablet: deaths from any cause	Trial comparisons
TNX-102 SL Tablet, 2.8 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/NCT02436096

GET https://conductscience.org/api/trials/v1/NCT02436096/events?page=2

API reference For AI assistants