Phase 2 Study of TD-9855 to Treat Fibromyalgia

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theravance Biopharma; Theravance Biopharma R & D, Inc.

Criteria

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)