Phase 2 Study of TD-9855 to Treat Fibromyalgia
A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)
1 other identifier
interventional
392
1 country
34
Brief Summary
The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2012
Shorter than P25 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2012
CompletedFirst Posted
Study publicly available on registry
September 26, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
March 4, 2022
CompletedMarch 4, 2022
February 1, 2022
1.2 years
September 20, 2012
February 9, 2022
February 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Fibromyalgia Impact Questionnaire (FIQ)
Day 43 (End of study treatment)
Patient Global Impression of Change (PGIC)
Day 43 (End of study treatment)
Study Arms (3)
TD-9855 Group 1
EXPERIMENTALGroup 1 to be dosed with TD-9855
TD-9855 Group 2
EXPERIMENTALGroup 2 to be dosed with TD-9855
Placebo
PLACEBO COMPARATORGroup to be dosed with Placebo
Interventions
Eligibility Criteria
You may qualify if:
- American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)
- Informed consent
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, 35801, United States
Dedicated Clinical Research
Goodyear, Arizona, 85395, United States
TriWest Research Associates, LLC
El Cajon, California, 92020, United States
Arroyo Medical Group, Inc.
Pismo Beach, California, 93449, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Coastal Connecticut Research, LLC
New London, Connecticut, 06320, United States
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
Meridien Research
Lakeland, Florida, 33805, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
GTC Research
Shawnee Mission, Kansas, 66218, United States
Beacon Clinical Research
Brockton, Massachusetts, 02301, United States
Beacon Clinical Research
New Bedford, Massachusetts, 02740, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Lillestol Research, LLC
Fargo, North Dakota, 58103, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Clinical Research Source, Inc.
Perrysburg, Ohio, 43551, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74104, United States
Sunstone Medical Research, LLC
Medford, Oregon, 97504, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Carolina Center for Rheumatology & Arthritis Care
Rock Hill, South Carolina, 29732, United States
Meridian Clinical Research
Dakota Dunes, South Dakota, 57049, United States
ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Swedish Rheumatology Research
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 32856281DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Monitor
- Organization
- Theravance Biopharma
Study Officials
- STUDY DIRECTOR
Medical Monitor
Theravance Biopharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2012
First Posted
September 26, 2012
Study Start
November 1, 2012
Primary Completion
January 1, 2014
Study Completion
April 1, 2014
Last Updated
March 4, 2022
Results First Posted
March 4, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.