Summary:
Pacific Institute of Medical Research is conducting a Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia.
Qualified Participants Must:
• Be 18 years of age or older
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Be able to give written informed consent
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Be able to complete subject-reported questionnaires per the investigator's judgment
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At screening, meet the 1990 American College of Rheumatology (ACR) criteria for FM, i.e. widespread pain present for at least 3 months and pain in at least 11 of 18 specific tender point sites. In addition, the 2010 ACR criteria must be met:
Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5, or WPI 3 to 6 and SS scale score ≥ 9
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Have symptoms present at a similar level for at least 3 months
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Not have a disorder that would otherwise explain the pain
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Have a ADPS of ≥ 4 on the 11-point numeric rating scale (NRS) over the past 7 days prior to randomization (based on completion of at least 4 daily pain diaries during the 7-day baseline period prior to randomization)
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Have documented evidence of a fundoscopic examination (with pupil dilation) within 12 months prior to screening or at screening
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Be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion if a Women of child-bearing potential (WOCBP).
Qualified Participants May Receive:
Free medication, Free examination, and compensation for time and travel.