Phase 2 Study of TD-9855 to Treat Fibromyalgia



Status:Completed
Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:18 - 65
Updated:9/15/2018
Start Date:November 2012
End Date:April 2014

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A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)

The purpose of this study study is to determine whether TD-9855 is effective in treating
patients with fibromyalgia.


Inclusion Criteria:

- • American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)

- Informed consent

- 18 to 65 years of age

- Discontinue therapy with adrenergic-acting drugs, and certain other medications

- Only acetaminophen or NSAID as rescue pain medication

- No narcotic pain meds or benzodiazepines

- Only non-benzodiazepines as rescue hypnotics

Exclusion Criteria:

- Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II
disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric
Interview (MINI)

- Major depression at screening by MINI when unable to be washed out of MDD meds
(investigator or provider's judgment)

- Risk of suicide (investigator opinion and/or C-SSRS)

- Recent history of substance or alcohol abuse

- BMI <18 or ≥45

- Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history
of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or
orthostatic tachycardia; untreated sleep apnea

- Abnormal lab values (liver, kidney, thyroid, and others)
We found this trial at
34
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Walnut creek, California 94598
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8420 S. Eastern Ave.
Las Vegas, Nevada 89123
702-898-2088
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1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
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342 Montauk Avenue
New London, Connecticut 06320
860-443-4567
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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8043 Cooper Creek Boulevard Suite 107
Bradenton, Florida 34201
(941) 747-7900
Florida Clinical Research Center, LLC Led by Andrew J. Cutler, M.D., Florida Clinical Research Center,...
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Brandon, Florida 33511
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Brockton, Massachusetts 02301
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Chattanooga, Tennessee 37421
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Dakota Dunes, South Dakota 57049
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Duncansville, Pennsylvania 16635
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El Cajon, California 92020
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Evansville, Indiana 47714
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Fargo, North Dakota 58103
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Goodyear, Arizona 85395
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Kansas City, Missouri 64114
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Lakeland, Florida 33805
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Mount Pleasant, South Carolina 29464
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New Bedford, Massachusetts 02740
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Omaha, Nebraska 68134
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Perrysburg, Ohio 43551
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Pismo Beach, California 93449
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Rock Hill, South Carolina 29732
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Seattle, Washington 98104
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Shawnee Mission, Kansas 66218
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Tulsa, Oklahoma 74104
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Williamsville, New York 14221
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Winston-Salem, North Carolina 27103
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