Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia



Status:Terminated
Conditions:Chronic Pain, Fibromyalgia, Neurology, Neurology, Neurology, Orthopedic, Rheumatology, Pain
Therapuetic Areas:Musculoskeletal, Neurology, Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 75
Updated:4/27/2018
Start Date:July 2016
End Date:September 2016

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A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The EFFIcacy and Safety of TNX-102 SL Tablets Taken Daily At Bedtime In Patients With FibRoMyalgia

The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets,
taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.

The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for
fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide
strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain,
sleep and other FM symptomatology.


Inclusion Criteria:

- Diagnosis of Primary Fibromyalgia (2010 ACR criteria)

- Male or female 18-75 years old

- Patients currently receiving pharmacologic treatment for depression should have been
clinically stable for at least 3 months prior to randomization, and on stable doses of
antidepressants during this 3 month time frame.

- Willing and able to withdraw specific therapies (ask PI)

- If female, medically acceptable form of contraception or not of child bearing
potential.

- Provide written informed consent to participate.

- Willing and able to comply with all protocol specified requirement.

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-out specific medications (ask PI)

- Known hypersensitivity to cyclobenzaprine

- Others: seizure disorders, severe/untreated sleep apnea, BMI>45
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