Trial · NCT02589275
A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients
NCT02589275, Phase 3, Completed, Tonix Pharmaceuticals, Inc.; results first posted 2024-12-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients. Trials, record NCT02589275. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02589275
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients
- NCT number
- NCT02589275
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 375 participants, actual
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Conditions
- Primary Fibromyalgia
- Interventions
- TNX-102 SL Tablet 2.8 mg
- First posted
- 2015-10-28
- Last updated
- 2025-02-20
- Results first posted
- 2024-12-11
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Newly Emergent Adverse Events | Up to 3 months from first dose | The number of patients with at least one adverse event which began after the first dose of TNX-102 SL in this open-label extension study. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Newly Emergent Adverse Events | Up to 3 months from first dose | Data is reported for all patients with AE data collected at the time when this study was terminated. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Newly Emergent Adverse Events | TNX-TNX | 77 | Participants | ||
| Newly Emergent Adverse Events | PBO-TNX | 132 | Participants |
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-TNX | 177 | |
| Overall Study | STARTED | PBO-TNX | 198 | |
| Overall Study | COMPLETED | TNX-TNX | 143 | |
| Overall Study | COMPLETED | PBO-TNX | 142 | |
| Overall Study | NOT COMPLETED | TNX-TNX | 34 | |
| Overall Study | NOT COMPLETED | PBO-TNX | 56 |
Source ClinicalTrials.gov
Adverse events14
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-TNX | 60 | 170 | |
| other | Hypoaesthesia Oral | Gastrointestinal disorders | PBO-TNX | 73 | 186 | |
| other | Parasthesia Oral | Gastrointestinal disorders | TNX-TNX | 9 | 170 | |
| other | Parasthesia Oral | Gastrointestinal disorders | PBO-TNX | 11 | 186 | |
| other | Tongue Discomfort | Gastrointestinal disorders | TNX-TNX | 5 | 170 | |
| other | Tongue Discomfort | Gastrointestinal disorders | PBO-TNX | 15 | 186 | |
| other | Product Taste Abnormal | Product Issues | TNX-TNX | 9 | 170 | |
| other | Product Taste Abnormal | Product Issues | PBO-TNX | 20 | 186 | |
| serious | Lymphadenopathy | Blood and lymphatic system disorders | TNX-TNX | 1 | 170 | |
| serious | Lymphadenopathy | Blood and lymphatic system disorders | PBO-TNX | 0 | 186 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TNX-TNX | 0 | 177 |
| Total, all-cause mortality | PBO-TNX | 0 | 198 |
| Total, other adverse events | TNX-TNX | 69 | 170 |
| Total, other adverse events | PBO-TNX | 86 | 186 |
| Total, serious adverse events | TNX-TNX | 2 | 170 |
| Total, serious adverse events | PBO-TNX | 0 | 186 |
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-TNX vs PBO-TNX: Newly Emergent Adverse Events | Trial comparisons |
| TNX-TNX vs PBO-TNX: deaths from any cause | Trial comparisons |
| TNX-TNX vs PBO-TNX: 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/NCT02589275
GET https://conductscience.org/api/trials/v1/NCT02589275/registered