BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was 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 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of primary Fibromyalgia (ACR criteria)

• Male or female 18-65 years old

• For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent 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-off specific medications (ask PI)

• Known hypersensitivity to cyclobenzaprine

• Others: seizure disorders, sleep apnea, continuous positive airway pressure (CPAP) use, BMI>40