Phase 3 N=519 Randomized Quadruple-blind Treatment

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

Fibromyalgia · Myofascial Pain Syndromes · Muscular Diseases · Musculoskeletal Diseases · Nervous System Diseases

Bottom Line

View on ClinicalTrials.gov: NCT02436096 ↗

Enrolled (actual)

519

Serious AEs

1.4%

Results posted

Feb 2025

Primary outcome: Primary: Proportion of Patients With ≥30% Pain Improvement — 58; 75 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: TNX-102 SL Tablet, 2.8mg (Drug); Placebo SL Tablet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tonix Pharmaceuticals, Inc.
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients With ≥30% Pain Improvement	58; 75	—
SECONDARY Patient's Global Impression of Change (PGIC)	42; 62	—
SECONDARY Change From Baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score	-8.2; -14.1	—
SECONDARY Change From Baseline to Week 12 in the FIQR Function Domain Score	-4.4; -10.3	—
SECONDARY Patient Reported Outcomes Measurement System (PROMIS) Sleep Disturbance	-4.7; -8.0	—
SECONDARY Weekly Average of Daily Sleep Quality Diary	-1.0; -1.8	—
SECONDARY Patient Reported Outcomes Measurement System (PROMIS) Fatigue	-4.2; -6.4	—
SECONDARY Weekly Average of Daily Pain Diary	-1.0; -1.5	—

Summary

The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology. The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.

Eligibility Criteria

Inclusion Criteria

Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
Male or female 18-75 years old
For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressant therapy
Willing and able to withdraw specific therapies (ask PI)
Medically acceptable form of contraception (female only)
Signed informed consent

Exclusion Criteria

Arthritis, lupus and other systemic auto-immune diseases
Regional or persistent pain that could interfere with assessment of fibromyalgia pain
Bipolar and psychotic disorders
Increased risk of suicide
Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
Inability to wash-out specific medications (ask PI)
Known hypersensitivity to cyclobenzaprine
Others: seizure disorders, severe/untreated sleep apnea, BMI>40

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02436096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.