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Completed

NCT Number: NCT01693692

Phase 2 Study of TD-9855 to Treat Fibromyalgia

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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rheumatology Associates of North Alabama, PC, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TD-9855 Group 1

Drug

TD-9855 Group 2

Drug

Placebo

Drug

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

    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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 26, 2012
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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