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COMPLETEDPhase 2NCT01693692

Phase 2 Study of TD-9855 to Treat Fibromyalgia

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

Lead sponsor: Theravance Biopharma•34 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Theravance Biopharma

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

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)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 4, 2022Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment392

Start dateNov 2012

Last updatedMar 4, 2022

Condition

Locations shown

Rheumatology Associates of North Alabama, PC

Huntsville, Alabama

Dedicated Clinical Research

Goodyear, Arizona

TriWest Research Associates, LLC

El Cajon, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2022Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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