Phase 2 Study of TD-9855 to Treat Fibromyalgia

Completed · Phase 2 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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

Key facts

Study ID

NCT01693692

Run by

Theravance Biopharma

People needed

392

Starts

2012-11-01

Expected to finish

2014-04-01

Last updated by the study team

2022-03-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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

You may not qualify if…

• 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)

Where it is running

• 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
• Compass Research, LLC — Orlando, Florida, United States
• Clinical Investigation Specialists, Inc. — Gurnee, Illinois, United States
• MediSphere Medical Research Center, LLC — Evansville, Indiana, United States
• GTC Research — Shawnee Mission, Kansas, United States
• Beacon Clinical Research — Brockton, Massachusetts, United States
• Beacon Clinical Research — New Bedford, Massachusetts, United States
• The Center for Pharmaceutical Research — Kansas City, Missouri, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Advanced Biomedical Research of America — Las Vegas, Nevada, United States
• Upstate Clinical Research Associates, LLC — Williamsville, New York, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• The Center for Clinical Research — Winston-Salem, North Carolina, United States
• Lillestol Research, LLC — Fargo, North Dakota, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Clinical Research Source, Inc. — Perrysburg, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.