Phase 2 Study of TD-9855 to Treat Fibromyalgia

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

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: TD-9855 Group 1
* Drug: TD-9855 Group 2
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-9855 Group 1<br>Group 1 to be dosed with TD-9855 | Drug: TD-9855 Group 1<br> <br> |
| Experimental: TD-9855 Group 2<br>Group 2 to be dosed with TD-9855 | Drug: TD-9855 Group 2<br> <br> |
| Placebo Comparator: Placebo<br>Group to be dosed with Placebo | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 43 (End of study treatment) | 
| 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. | Day 43 (End of study treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia