An Open-label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
An Open-label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
This is an open-label study of DS-5565 in subjects who either completed participation in a preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430), DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Eligible subjects will be assigned to receive open-label DS-5565 for 52 weeks. All subjects will receive DS-5565 15 mg once daily (QD) for the first three weeks of the treatment period. After three weeks, subjects may be titrated to 15 mg twice daily (BID) based on protocol-specified criteria.
Inclusion Criteria:
De Novo Subjects
Age ≥ 18 years
Able to give written informed consent
Able to complete subject-reported questionnaires per the investigator's judgment
At screening, subjects must 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:
ADPS of ≥ 4 on the 11-point numeric rating scale (NRS) over the past 7 days prior to first dose (based on completion of at least 4 daily pain diaries during the 7-day baseline period)
Subject must have documented evidence of a fundoscopic examination (with pupil dilation) within 12 months prior to screening or at screening
Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion
Exclusion Criteria:
For De Novo Subjects Only
Nizhniy Novgarad, Russia