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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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 strong 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tonix Pharmaceuticals, Inc.
• Treatments: Cyclobenzaprine

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.

• Unability to wash-out specific medications (ask PI)

• Known hypersensitivity to cyclobenzaprine

• Others: seizure disorders, severe/untreated sleep apnea, BMI>40