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Phase 2 Study of TD-9855 to Treat Fibromyalgia

This study is currently recruiting participants.
Verified May 2013 by Theravance, Inc.
Sponsor:
Information provided by (Responsible Party):
Theravance, Inc.
ClinicalTrials.gov Identifier:
NCT01693692
First received: September 20, 2012
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Fibromyalgia
 Drug: TD-9855 Group 1
Drug: TD-9855 Group 2
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Theravance, Inc.:

Primary Outcome Measures:
  • Percent change in mean pain score based on the mean of the last 7 daily pain NRS scores from the daily pain diaries [ Time Frame: Up to 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: From Run-In through End of Study (Day 63) ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: From Baseline through End of Study (Day 63) ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)

    • Informed consent
    • 18 to 59 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693692

Contacts
Contact: Peter St. Wecker, Ph.D. 650-808-4136 Pstwecker@theravance.com

  Show 39 Study Locations
Sponsors and Collaborators
Theravance, Inc.
  More Information

No publications provided

Responsible Party: Theravance, Inc.
ClinicalTrials.gov Identifier: NCT01693692     History of Changes
Other Study ID Numbers: 0092
Study First Received: September 20, 2012
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance, Inc.:
Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013