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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02234583
Study type Interventional
Source Daiichi Sankyo, Inc.
Contact
Status Completed
Phase Phase 3
Start date February 4, 2015
Completion date April 19, 2017

See also
  Status Clinical Trial Phase
Completed NCT02146430 - Treatment of Pain Associated With Fibromyalgia Phase 3
Completed NCT02187159 - Treatment of Pain Associated With Fibromyalgia Phase 3
Completed NCT02187471 - Treatment of Pain Associated With Fibromyalgia Phase 3
Completed NCT01773993 - Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)