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

Tonix Pharmaceuticals

Status and phase

Completed

Phase 3

Phase 2

Conditions

Primary Fibromyalgia

Treatments

Drug: TNX-102 SL 2.8mg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01903265

TNX-CY-F202

Details and patient eligibility

About

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.

Enrollment

205 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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