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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Primary Fibromyalgia

In brief

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.

Key facts

Study ID

NCT01903265

Run by

Tonix Pharmaceuticals, Inc.

People needed

205

Starts

2013-09-01

Expected to finish

2014-09-01

Last updated by the study team

2016-12-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 107 Scripps Drive — Sacramento, California, United States
• Radiant Research, Inc. — Denver, Colorado, United States
• 16176 Cortez Boulevard — Brooksville, Florida, United States
• 100 West Gore Street — Orlando, Florida, United States
• 3401 North Central Avenue — Chicago, Illinois, United States
• 71 Thomas Johnson Drive — Frederick, Maryland, United States
• 370 Faunce Corner Road — North Dartmouth, Massachusetts, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• CRC of Jackson, LLC — Jackson, Mississippi, United States
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
• 1275 Olentangy River Road — Columbus, Ohio, United States
• 18660 Bagley Road — Middleburg Heights, Ohio, United States
• 1001 South Market Street — Mechanicsburg, Pennsylvania, United States
• 322 Memorial Drive — Greer, South Carolina, United States
• 1002 E. South Temple — Salt Lake City, Utah, United States
• 1951 152nd Place NE — Bellevue, Washington, United States
• 601 Broadway — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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