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

Status:	Completed
Conditions:	Fibromyalgia, Pain
Therapuetic Areas:	Musculoskeletal, Rheumatology
Healthy:	No
Age Range:	18 - 65
Updated:	4/21/2016
Start Date:	September 2013
End Date:	November 2015

A Phase 2b, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken at Bedtime in Patients With Fibromyalgia

TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime has
shown promise as a treatment of fibromyalgia, but the drug required new formulation
technology for bedtime use. 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.

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

- Increase 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, sleep apnea, CPAP use, BMI>40

We found this trial at

sites

71 Thomas Johnson Drive

Frederick, Maryland 21702

from

Frederick, MD