Phase 2 Study of TD-9855 to Treat Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693692
• Other study ID #: 0092
• Status: Completed
• Phase: Phase 2
• Start date: November 2012
• Est. completion date: April 2014

Study information

• Verified date: February 2022
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• TD-9855 Group 1

• TD-9855 Group 2

• Placebo

Locations

Country	Name	City	State
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	PAB Clinical Research	Brandon	Florida
United States	Beacon Clinical Research	Brockton	Massachusetts
United States	ClinSearch, LLC	Chattanooga	Tennessee
United States	University of Cincinnati	Cincinnati	Ohio
United States	Meridian Clinical Research	Dakota Dunes	South Dakota
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	TriWest Research Associates, LLC	El Cajon	California
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Lillestol Research, LLC	Fargo	North Dakota
United States	Dedicated Clinical Research	Goodyear	Arizona
United States	Clinical Investigation Specialists, Inc.	Gurnee	Illinois
United States	Rheumatology Associates of North Alabama, PC	Huntsville	Alabama
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	Meridien Research	Lakeland	Florida
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Sunstone Medical Research, LLC	Medford	Oregon
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Beacon Clinical Research	New Bedford	Massachusetts
United States	Coastal Connecticut Research, LLC	New London	Connecticut
United States	Renstar Medical Research	Ocala	Florida
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Compass Research, LLC	Orlando	Florida
United States	Clinical Research Source, Inc.	Perrysburg	Ohio
United States	Arroyo Medical Group, Inc.	Pismo Beach	California
United States	Wake Research Associates	Raleigh	North Carolina
United States	Carolina Center for Rheumatology & Arthritis Care	Rock Hill	South Carolina
United States	Swedish Rheumatology Research	Seattle	Washington
United States	GTC Research	Shawnee Mission	Kansas
United States	Tulsa Clinical Research, LLC	Tulsa	Oklahoma
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	Upstate Clinical Research Associates, LLC	Williamsville	New York
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Week 6
Secondary	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.	Day 43 (End of study treatment)
Secondary	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.	Day 43 (End of study treatment)