The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
392
Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries
Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.
Time frame: Baseline and Week 6
Fibromyalgia Impact Questionnaire (FIQ)
FIQ score is based on the total score from 0 to 100 gained from 10 questions, where a lower total score represents less impact from fibromyalgia.
Time frame: Day 43 (End of study treatment)
Patient Global Impression of Change (PGIC)
PGIC score is based on a 7-category scale where a score of 1 indicates the participant's condition is very much improved, and a score of 7 indicates the participant's condition is very much worse.
Time frame: Day 43 (End of study treatment)
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Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States
Dedicated Clinical Research
Goodyear, Arizona, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Arroyo Medical Group, Inc.
Pismo Beach, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Coastal Connecticut Research, LLC
New London, Connecticut, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, United States
PAB Clinical Research
Brandon, Florida, United States
Meridien Research
Lakeland, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
...and 24 more locations