Clinical trial NCT01693692: Phase 2 Study of TD-9855 to Treat Fibromyalgia
Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2012-09-26
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: 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
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Day 43 (End of study treatment)
measure: Patient Global Impression of Change (PGIC)
timeFrame: Day 43 (End of study treatment)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama, PC
state: Alabama
city: Goodyear
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: El Cajon
country: United States
facility: TriWest Research Associates, LLC
state: California
city: Pismo Beach
country: United States
facility: Arroyo Medical Group, Inc.
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: New London
country: United States
facility: Coastal Connecticut Research, LLC
state: Connecticut
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Gurnee
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Shawnee Mission
country: United States
facility: GTC Research
state: Kansas
city: Brockton
country: United States
facility: Beacon Clinical Research
state: Massachusetts
city: New Bedford
country: United States
facility: Beacon Clinical Research
state: Massachusetts
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates, LLC
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research, LLC
state: North Dakota
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source, Inc.
state: Ohio
city: Tulsa
country: United States
facility: Tulsa Clinical Research, LLC
state: Oklahoma
city: Medford
country: United States
facility: Sunstone Medical Research, LLC
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Center for Rheumatology & Arthritis Care
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research
state: South Dakota
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Seattle
country: United States
facility: Swedish Rheumatology Research
state: Washington
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kanodia J, Lo A, Baldwin RM, Graham RA, Bourdet DL. Pharmacokinetics of Ampreloxetine, a Norepinephrine Reuptake Inhibitor, in Healthy Subjects and Adults with Attention-Deficit/Hyperactive Disorder or Fibromyalgia Pain. Clin Pharmacokinet. 2021 Jan;60(1):121-131. doi: 10.1007/s40262-020-00918-7.