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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
392

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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