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

Tonix Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Myofascial Pain Syndromes; Fibromyalgia; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Diseases; Nervous System Diseases; Rheumatic Diseases

Treatments: Drug: Placebo SL Tablet; Drug: TNX-102 SL Tablet, 2.8mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02436096

TNX-CY-F301

Details and patient eligibility

About

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.

Enrollment: 519 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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519 participants in 2 patient groups, including a placebo group

TNX-102 SL Tablet, 2.8 mg

Experimental group

Description:

1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks

Treatment:

Drug: TNX-102 SL Tablet, 2.8mg

Placebo SL Tablet

Placebo Comparator group

Description:

1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks

Treatment:

Drug: Placebo SL Tablet