A Phase 3 interventional study of TNX-102 SL Tablet, 2.8 mg and Placebo SL Tablet in Fibromyalgia, Myofascial Pain Syndromes and Muscular Diseases, sponsored by Tonix Pharmaceuticals, Inc.. Terminated at 32 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by Tonix Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.
The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Tonix Pharmaceuticals, Inc. is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 12 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 12 weeks
Drug: TNX-102 SL Tablet, 2.8 mg
1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks
Drug: Placebo SL Tablet
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
Also known as: Low dose cyclobenzaprine sublingual tablets
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
Also known as: Placebo sublingual tablets
Weekly Mean Pain Score
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) numeric response scale (NRS). A score of 0 indicates "no pain at all", and a score of 10 indicates "worst possible pain".
Time frame: Day 1, Week 12
Patient's Global Impression of Change (PGIC)
Proportion of patients with a PGIC rating of "very much improved" or "much improved" at Week 12.The PGIC is a 7-point scale (1=very much improved; 7=very much worse) that assesses the patient's perception of the overall change in his/her fibromyalgia symptoms since entering the study.
Time frame: Week 12
Fibromyalgia Impact Questionnaire (FIQR) Revised, Symptoms Domain
Change from Baseline in the FIQR symptoms domain score at Week 12. The FIQ-R symptom domain is composed of 10 questions. All questions are based on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." Symptom domain scores range from 0-100, with higher scores reflecting worse status.
Time frame: Day 1, Week 12
Fibromyalgia Impact Questionnaire (FIQR) Revised, Functional Domain Score
Change from Baseline in the FIQR function domain score at Week 12. The FIQ-R functional domain score is composed of 9 questions which are rated on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." FIQ-R functional domain scores can range from 0-90, with higher scores reflecting worsening status.
Time frame: Day 1, Week 12
Daily Diary Sleep
Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12. Daily sleep quality was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse sleep.
Time frame: Week 12
Patient Reported Outcomes Measurement System (PROMIS), Sleep Disturbance
Change from Baseline in the PROMIS score for sleep disturbance at Week 12. The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).
Time frame: Day 1, Week 12
Patient Reported Outcomes Measurement System (PROMIS), Fatigue
Change from Baseline in the PROMIS score for fatigue at Week 12. The Patient-Reported Outcome Measurement Information System (PROMIS) fatigue instrument consists of 8 items in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).
Time frame: Week 12
Daily Diary Pain
Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Weekly averages were calculated based on the reported daily scores.
Time frame: Week -1 (Day -7 to Day -1), Week 12
| Milestone | Placebo SL Tablet | TNX-102 SL Tablet, 2.8 mg |
|---|---|---|
| Started | 27 | 24 |
| Completed | 0 | 0 |
| Not completed | 27 | 24 |
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) numeric response scale (NRS). A score of 0 indicates "no pain at all", and a score of 10 indicates "worst possible pain".
No measurements were reported for this outcome.
Proportion of patients with a PGIC rating of "very much improved" or "much improved" at Week 12.The PGIC is a 7-point scale (1=very much improved; 7=very much worse) that assesses the patient's perception of the overall change in his/her fibromyalgia symptoms since entering the study.
No measurements were reported for this outcome.
Change from Baseline in the FIQR symptoms domain score at Week 12. The FIQ-R symptom domain is composed of 10 questions. All questions are based on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." Symptom domain scores range from 0-100, with higher scores reflecting worse status.
No measurements were reported for this outcome.
Change from Baseline in the FIQR function domain score at Week 12. The FIQ-R functional domain score is composed of 9 questions which are rated on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." FIQ-R functional domain scores can range from 0-90, with higher scores reflecting worsening status.
No measurements were reported for this outcome.
Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12. Daily sleep quality was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse sleep.
No measurements were reported for this outcome.
Change from Baseline in the PROMIS score for sleep disturbance at Week 12. The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).
No measurements were reported for this outcome.
Change from Baseline in the PROMIS score for fatigue at Week 12. The Patient-Reported Outcome Measurement Information System (PROMIS) fatigue instrument consists of 8 items in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).
No measurements were reported for this outcome.
Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Weekly averages were calculated based on the reported daily scores.
No measurements were reported for this outcome.
Collected over Approximately 7 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo SL Tablet | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| TNX-102 SL Tablet, 2.8 mg | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Continuous(years) | Placebo SL Tablet | TNX-102 SL Tablet, 2.8 mg | Total |
|---|---|---|---|
| Mean | 51.4 ± 10.10 | 52.1 ± 7.45 | 51.7 ± 8.87 |
| Sex: Female, Male(Participants) | Placebo SL Tablet | TNX-102 SL Tablet, 2.8 mg | Total |
|---|---|---|---|
| Female | 24 | 23 | 47 |
| Male | 1 | 1 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Placebo SL Tablet | TNX-102 SL Tablet, 2.8 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 22 | 22 | 44 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Placebo SL Tablet | TNX-102 SL Tablet, 2.8 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 1 | 5 |
| White | 19 | 22 | 41 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 1 | 5 |
| Region of Enrollment(participants) | Placebo SL Tablet | TNX-102 SL Tablet, 2.8 mg | Total |
|---|---|---|---|
| United States | 27 | 24 | 51 |
Ran from Jul 2016 to primary completion in Sep 2016, 1 month.
Results were first posted in Feb 2025, 8 years 5 months after primary completion. A results delay was requested in Apr 2018.
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Studies of the drug tested here: Cyclobenzaprine