Phase 2 Study of TD-9855 to Treat Fibromyalgia

Theravance Biopharma

Status and phase: Completed; Phase 2

Conditions: Fibromyalgia

Treatments: Drug: TD-9855 Group 2; Drug: Placebo; Drug: TD-9855 Group 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01693692

0092

Details and patient eligibility

About

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

Enrollment: 392 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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392 participants in 3 patient groups, including a placebo group

TD-9855 Group 1

Experimental group

Description:

Group 1 to be dosed with TD-9855

Treatment:

Drug: TD-9855 Group 1

TD-9855 Group 2

Experimental group

Description:

Group 2 to be dosed with TD-9855

Treatment:

Drug: TD-9855 Group 2

Placebo

Placebo Comparator group

Description:

Group to be dosed with Placebo

Treatment:

Drug: Placebo