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

Date de début de l'étude : 1 novembre 2012

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)