Phase 2 Study of TD-9855 to Treat Fibromyalgia

February 9, 2022 updated by: Theravance Biopharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

392

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Rheumatology Associates of North Alabama, PC
    • Arizona
      • Goodyear, Arizona, United States, 85395
        • Dedicated Clinical Research
    • California
      • El Cajon, California, United States, 92020
        • TriWest Research Associates, LLC
      • Pismo Beach, California, United States, 93449
        • Arroyo Medical Group, Inc.
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Coastal Connecticut Research, LLC
    • Florida
      • Bradenton, Florida, United States, 34201
        • Florida Clinical Research Center, LLC
      • Brandon, Florida, United States, 33511
        • PAB Clinical Research
      • Lakeland, Florida, United States, 33805
        • Meridien Research
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Orlando, Florida, United States, 32806
        • Compass Research, LLC
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Clinical Investigation Specialists, Inc.
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Medisphere Medical Research Center, Llc
    • Kansas
      • Shawnee Mission, Kansas, United States, 66218
        • Gtc Research
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Beacon Clinical Research
      • New Bedford, Massachusetts, United States, 02740
        • Beacon Clinical Research
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • The Center for Pharmaceutical Research
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Advanced Biomedical Research of America
    • New York
      • Williamsville, New York, United States, 14221
        • Upstate Clinical Research Associates, LLC
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Lillestol Research, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
      • Perrysburg, Ohio, United States, 43551
        • Clinical Research Source, Inc.
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Tulsa Clinical Research, LLC
    • Oregon
      • Medford, Oregon, United States, 97504
        • Sunstone Medical Research, LLC
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
      • Rock Hill, South Carolina, United States, 29732
        • Carolina Center for Rheumatology & Arthritis Care
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Meridian Clinical Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • ClinSearch, LLC
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Rheumatology Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TD-9855 Group 1
Group 1 to be dosed with TD-9855
Drug: TD-9855 Group 1
Experimental: TD-9855 Group 2
Group 2 to be dosed with TD-9855
Drug: TD-9855 Group 2
Placebo Comparator: Placebo
Group to be dosed with Placebo
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline and Week 6
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: Day 43 (End of study treatment)
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)
Patient Global Impression of Change (PGIC)
Time Frame: Day 43 (End of study treatment)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theravance Biopharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

September 20, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (Estimate)

September 26, 2012

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0092

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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