NCT04508621: RALLY

A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

Completed Phase 3 Results posted Last updated 18 December 2023

What this trial tests

Phase 3 trial testing TNX-102 SL in Fibromyalgia in 514 participants. Completed in 1 November 2021.

Timeline

22 July 2020

Primary endpoint
1 November 2021

1 November 2021

Quick facts

Lead sponsor	Tonix Pharmaceuticals, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	514
Start date	22 July 2020
Primary completion	1 November 2021
Estimated completion	1 November 2021
Sites	36 locations across United States

Drugs / interventions tested

• TNX-102 SL — full drug profile →
• Placebo SL Tablet — full drug profile →

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Tonix Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline to Week 14 in the Numerical Rating Scale (NRS) Weekly Average of Daily Self-reported Average Pain Severity Scores. Primary · 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).

Group	Value	95% CI
TNX-102 SL Tablet, 5.6 mg	-1.6	-1.8 – -1.3
Placebo SL Tablet	-1.3	-1.5 – -1.1

Number of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved" Secondary · 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.

Group	Value	95% CI
TNX-102 SL Tablet, 5.6 mg	76
Placebo SL Tablet	56

Change From Baseline to Week 14 in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score. Secondary · 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.

Group	Value	95% CI
TNX-102 SL Tablet, 5.6 mg	-15.3	-17.6 – -13.1
Placebo SL Tablet	-12.0	-14.2 – -9.8

Change From Baseline to Week 14 in the FIQ-R Function Domain Score Secondary · 14 weeks

The FIQ-R is a validated questionnaire. Score on the function domain range from 0 to 90 where a higher score means worse outcome.

Group	Value	95% CI
TNX-102 SL Tablet, 5.6 mg	-8.8	-10.9 – -6.7
Placebo SL Tablet	-8.4	-10.5 – -6.4

Change From Baseline to Week 14 in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance Secondary · 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.

Group	Value	95% CI
TNX-102 SL Tablet, 5.6 mg	-7.4	-8.6 – -6.2
Placebo SL Tablet	-5.1	-6.2 – -4.0

Change From Baseline to Week 14 in the PROMIS Score for Fatigue Secondary · 14 weeks

The PROMIS fatigue short form 8a consist 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 Tablet, 5.6 mg	-6.6	-7.7 – -5.5
Placebo SL Tablet	-5.4	-6.4 – -4.3

Change From Baseline to Week 14 in the Weekly Average of the Daily Diary Assessment of Sleep Quality Secondary · 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).

Group	Value	95% CI
TNX-102 SL Tablet, 5.6 mg	-1.5	-1.7 – -1.3
Placebo SL Tablet	-1.3	-1.5 – -1.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 14 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TNX-102 SL Tablet, 5.6 mg

Serious: 6/256 (2%)

Deaths: 0/256

Placebo SL Tablet

Serious: 0/258 (0%)

Deaths: 0/258

Serious adverse events (7 terms)

Reaction	System	TNX-102 SL Tablet, 5.6 mg	Placebo SL Tablet
COVID-19 pneumonia	Infections and infestations	—	—
Localized infection	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Pancreatitis	Gastrointestinal disorders	—	—
Bile duct stone	Hepatobiliary disorders	—	—
Forearm fracture	Injury, poisoning and procedural complications	—	—
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	TNX-102 SL Tablet, 5.6 mg	Placebo SL Tablet
Hypoaesthesia oral	Gastrointestinal disorders	—	—
Product taste abnormal	Product Issues	—	—
Oral discomfort	Gastrointestinal disorders	—	—
Tongue discomfort	Gastrointestinal disorders	—	—

Most-reported serious reactions: COVID-19 pneumonia, Localized infection, Pneumonia, Pancreatitis, Bile duct stone, Forearm fracture, Invasive ductal breast carcinoma.

Data from ClinicalTrials.gov NCT04508621 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pain relief by targeting nonrestorative sleep in fibromyalgia: a phase 3 randomized trial of bedtime sublingual cyclobenzaprine.
   Lederman S, Arnold LM, Vaughn B, Engels JM, et al · · 2026 · cited 8× · PMID 40627411 · DOI 10.1093/pm/pnaf089
2. Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
   Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497