Phase 2 Study of TD-9855 to Treat Fibromyalgia

Phase 2

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: Placebo; Drug: TD-9855 Group 1; Drug: TD-9855 Group 2

• Registration Number: NCT01693692
• Lead Sponsor: Theravance Biopharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-26
• Study Start: 2012-11
• Primary Completion: 2014-01
• Study Completion: 2014-04
• Disposition First Submitted: 2018-09-10
• Disposition First Submitted QC: 2018-09-10
• Disposition First Posted: 2018-09-13
• Status Verified: 2022-02
• Results First Submitted: 2022-02-09
• Results First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Results First Posted: 2022-03-04
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Group to be dosed with Placebo
TD-9855 Group 1	TD-9855 Group 1	Group 1 to be dosed with TD-9855
TD-9855 Group 2	TD-9855 Group 2	Group 2 to be dosed with TD-9855

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnaire (FIQ)	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.
Patient Global Impression of Change (PGIC)	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.

Trial Locations

Locations (32)

Rheumatology Associates of North Alabama, PC; 🇺🇸 Huntsville, Alabama, United States

Dedicated Clinical Research; 🇺🇸 Goodyear, Arizona, United States

TriWest Research Associates, LLC; 🇺🇸 El Cajon, California, United States

Arroyo Medical Group, Inc.; 🇺🇸 Pismo Beach, California, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

Coastal Connecticut Research, LLC; 🇺🇸 New London, Connecticut, United States

Florida Clinical Research Center, LLC; 🇺🇸 Bradenton, Florida, United States

PAB Clinical Research; 🇺🇸 Brandon, Florida, United States

Meridien Research; 🇺🇸 Lakeland, Florida, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

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