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A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Phase 3 trial testing TNX-102 SL in Fibromyalgia in 503 participants. Completed in 29 October 2020.
| Lead sponsor | Tonix Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 503 |
| Start date | 9 December 2019 |
| Primary completion | 29 October 2020 |
| Estimated completion | 29 October 2020 |
| Sites | 39 locations across United States |
Tonix Pharmaceuticals, Inc. — full company profile →
Adults 18 to 65, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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).
| Group | Value | 95% CI |
|---|---|---|
| TNX-102 SL Tablets, 5.6 mg | -1.9 | -2.1 – -1.7 |
| Placebo SL Tablet | -1.5 | -1.7 – -1.3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| TNX-102 SL Tablets, 5.6 mg | 93 | |
| Placebo SL Tablet | 75 |
The FIQ-R is a validated questionnaire. Scores on the symptoms domain range from 0 to 100 where a higher score means worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| TNX-102 SL Tablets, 5.6 mg | -18.4 | -20.8 – -16.0 |
| Placebo SL Tablet | -14.0 | -16.4 – -11.7 |
The FIQ-R is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome.
| Group | Value | 95% CI |
|---|---|---|
| TNX-102 SL Tablets, 5.6 mg | -13.6 | -16.1 – -11.2 |
| Placebo SL Tablet | -9.3 | -11.7 – -6.8 |
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.
| Group | Value | 95% CI |
|---|---|---|
| TNX-102 SL Tablets, 5.6 mg | -9.5 | -10.7 – -8.2 |
| Placebo SL Tablet | -6.5 | -7.7 – -5.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| TNX-102 SL Tablets, 5.6 mg | -8.0 | -9.1 – -6.9 |
| Placebo SL Tablet | -6.2 | -7.4 – -5.0 |
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).
| Group | Value | 95% CI |
|---|---|---|
| TNX-102 SL Tablets, 5.6 mg | -2.0 | -2.3 – -1.8 |
| Placebo SL Tablet | -1.5 | -1.7 – -1.2 |
Time frame: 14 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | TNX-102 SL Tablets, 5.6 mg | Placebo SL Tablet |
|---|---|---|---|
| Spinal compression fracture | Injury, poisoning and procedural complications | — | — |
| Pneumonia | Infections and infestations | — | — |
| Coeliac artery compression syndrome | Gastrointestinal disorders | — | — |
| Corona virus infection | Infections and infestations | — | — |
| Femoral neck fracture | Injury, poisoning and procedural complications | — | — |
| Hypotention | Vascular disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | — | — |
| Femur fracture | Injury, poisoning and procedural complications | — | — |
| Foot fracture | Injury, poisoning and procedural complications | — | — |
| Joint dislocation | Injury, poisoning and procedural complications | — | — |
| Ulna fracture | Injury, poisoning and procedural complications | — | — |
| Road traffic accident | Injury, poisoning and procedural complications | — | — |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | — | — |
| Reaction | System | TNX-102 SL Tablets, 5.6 mg | Placebo SL Tablet |
|---|---|---|---|
| Hypoaesthesia oral | Gastrointestinal disorders | — | — |
| Paraesthesia oral | Gastrointestinal disorders | — | — |
| Dysguesia | Nervous system disorders | — | — |
Most-reported serious reactions: Spinal compression fracture, Pneumonia, Coeliac artery compression syndrome, Corona virus infection, Femoral neck fracture, Hypotention, Colitis, Thoracic vertebral fracture.
Data from ClinicalTrials.gov NCT04172831 adverse events section.
This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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