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Units

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Financing

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Brief description/objective

This is a randomized, double-blind, double-dummy,
placebo- and active controlled, multi-center study of
DS-5565 in subjects with pain associated with FM.
Eligible subjects will be randomized in the ratio of 1:1:1:1
to receive 13 weeks of treatment with DS-5565 15 mg once
daily (QD), DS-5565 15 mg twice daily (BID), placebo, or
pregabalin 150 mg BID. During the first week of
treatment, all subjects randomized to DS-5565 (regardless
of dose) will receive 15 mg QD and all subjects
randomized to pregabalin will receive 75 mg BID.
Subjects randomized to DS-5565 15 mg QD will continue
to receive 15 mg QD for the remaining 12 weeks, subjects
randomized to DS-5565 15 mg BID will receive 15 mg
BID for the remaining 12 weeks, and subjects randomized
to pregabalin 150 mg BID will receive pregabalin 150 mg
BID for the remaining 12 weeks. After Week 13 (Visit 11),
there will be a 1-week, double-blind tapering period during
which subjects randomized to pregabalin 150 mg BID will
be tapered off and all other subjects will receive placebo.
Subjects completing this study may be eligible to transition
into a separate 52-week safety study.