A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

Phase

3

Condition

Musculoskeletal Diseases

Fibromyalgia

Dystonias

Treatment

TNX-102 SL Tablet, 2.8mg

Placebo SL Tablet

Clinical Study ID

NCT02436096

TNX-CY-F301

Ages 18-75
All Genders

Study Summary

The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
Male or female 18-75 years old
For patients with major depressive disorders only: clinically stable, no suicidalrisk and stable anti-depressant therapy
Willing and able to withdraw specific therapies (ask PI)
Medically acceptable form of contraception (female only)
Signed informed consent

Exclusion

Exclusion Criteria:

Arthritis, lupus and other systemic auto-immune diseases
Regional or persistent pain that could interfere with assessment of fibromyalgiapain
Bipolar and psychotic disorders
Increased risk of suicide
Significant clinical (cardiac, systemic infection, systemic corticosteroidrequirement, 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>40

Study Design

TNX-102 SL Tablet, 2.8mg

3

April 01, 2015

September 30, 2016

Connect with a study center

Birmingham, Alabama 35216
United States
Site Not Available
Phoenix, Arizona 85032
United States
Site Not Available
Sacramento, California 95825
United States
Site Not Available
San Diego, California 92103
United States
Site Not Available
Brandon, Florida 33511
United States
Site Not Available
DeLand, Florida 32720
United States
Site Not Available
Lakeland, Florida 33805
United States
Site Not Available
Ocala, Florida 34471
United States
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Orlando, Florida 32806
United States
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Tampa, Florida 33613
United States
Site Not Available
West Palm Beach, Florida 33409
United States
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Atlanta, Georgia 30331
United States
Site Not Available
Columbus, Georgia 31904
United States
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Smyrna, Georgia 30080
United States
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Evansville, Indiana 47714
United States
Site Not Available
North Dartmouth, Massachusetts 02747
United States
Site Not Available
Ann Arbor, Michigan 48104
United States
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Jackson, Mississippi 39202
United States
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Williamsville, New York 14221
United States
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Cincinnati, Ohio 45206
United States
Site Not Available
Middleburg Heights, Ohio 44130
United States
Site Not Available
Medford, Oregon 97504
United States
Site Not Available
Portland, Oregon 97210
United States
Site Not Available
Allentown, Pennsylvania 18104
United States
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Warwick, Rhode Island 02888
United States
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Greer, South Carolina 29650
United States
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Mount Pleasant, South Carolina 29464
United States
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Mt. Pleasant, South Carolina 29464
United States
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Dallas, Texas 75231
United States
Site Not Available
Salt Lake City, Utah 84102
United States
Site Not Available
Charlottesville, Virginia 22911
United States
Site Not Available
Norfolk, Virginia 23507
United States
Site Not Available
Bellevue, Washington 98007
United States
Site Not Available
Seattle, Washington 98104
United States
Site Not Available
Kenosha, Wisconsin 53142
United States
Site Not Available

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