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Phase 2 Study of TD-9855 to Treat Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TD-9855 Group 1
TD-9855 Group 2
Placebo
Sponsored by
Theravance Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Rheumatology Associates of North Alabama, PC
  • Dedicated Clinical Research
  • TriWest Research Associates, LLC
  • Arroyo Medical Group, Inc.
  • Diablo Clinical Research, Inc.
  • Coastal Connecticut Research, LLC
  • Florida Clinical Research Center, LLC
  • PAB Clinical Research
  • Meridien Research
  • Renstar Medical Research
  • Compass Research, LLC
  • Clinical Investigation Specialists, Inc.
  • MediSphere Medical Research Center, LLC
  • GTC Research
  • Beacon Clinical Research
  • Beacon Clinical Research
  • The Center for Pharmaceutical Research
  • Meridian Clinical Research
  • Advanced Biomedical Research of America
  • Upstate Clinical Research Associates, LLC
  • Wake Research Associates
  • The Center for Clinical Research
  • Lillestol Research, LLC
  • University of Cincinnati
  • Clinical Research Source, Inc.
  • Tulsa Clinical Research, LLC
  • Sunstone Medical Research, LLC
  • Altoona Center for Clinical Research
  • Omega Medical Research
  • Coastal Carolina Research Center
  • Carolina Center for Rheumatology & Arthritis Care
  • Meridian Clinical Research
  • ClinSearch, LLC
  • Swedish Rheumatology Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

TD-9855 Group 1

TD-9855 Group 2

Placebo

Arm Description

Group 1 to be dosed with TD-9855

Group 2 to be dosed with TD-9855

Group to be dosed with Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 20, 2012
Last Updated
February 9, 2022
Sponsor
Theravance Biopharma
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1. Study Identification

Unique Protocol Identification Number
NCT01693692
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
392 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TD-9855 Group 1
Arm Type
Experimental
Arm Description
Group 1 to be dosed with TD-9855
Arm Title
TD-9855 Group 2
Arm Type
Experimental
Arm Description
Group 2 to be dosed with TD-9855
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group to be dosed with Placebo
Intervention Type
Drug
Intervention Name(s)
TD-9855 Group 1
Intervention Type
Drug
Intervention Name(s)
TD-9855 Group 2
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Description
Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.
Time Frame
Baseline and Week 6
Secondary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
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.
Time Frame
Day 43 (End of study treatment)
Title
Patient Global Impression of Change (PGIC)
Description
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.
Time Frame
Day 43 (End of study treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Rheumatology Associates of North Alabama, PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Dedicated Clinical Research
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
TriWest Research Associates, LLC
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Arroyo Medical Group, Inc.
City
Pismo Beach
State/Province
California
ZIP/Postal Code
93449
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Coastal Connecticut Research, LLC
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Meridien Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Clinical Investigation Specialists, Inc.
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
GTC Research
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
Beacon Clinical Research
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Beacon Clinical Research
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Upstate Clinical Research Associates, LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Lillestol Research, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Clinical Research Source, Inc.
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
Tulsa Clinical Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Sunstone Medical Research, LLC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Carolina Center for Rheumatology & Arthritis Care
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Meridian Clinical Research
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Swedish Rheumatology Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Citations:
PubMed Identifier
32856281
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.
Results Reference
derived

Learn more about this trial

Phase 2 Study of TD-9855 to Treat Fibromyalgia

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