Fibromyalgia Research Studies
Fibromyalgia Study Details - Click Here
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. Study Duration: The total study duration (for an individual subject’s participation) will be approximately 21 weeks, including a screening period (approximately 3 weeks, but no longer than 35 days, including a washout period [if applicable] and a 1-week baseline period), treatment period (13 weeks of double-blind treatment), tapering period (1 week, including a telephone contact at 3 days after the End-of-Treatment visit), and follow-up period (4 weeks, a clinic visit at 1 week and a telephone contact at 4 weeks after the End-of- Tapering visit). In the case of subjects who complete the treatment and tapering periods in this study and transition into a separate open-label extension study (DS5565-AE312), the follow-up period will not apply. Therefore, Visits 14 and 15 (Weeks 15 and 18) are only for subjects who do not enroll in the open-label extension study. Subjects who do enroll in the open-label extension study will complete Visit 1 of the open-label extension study on the same day as Visit 13 (Week 14) of this study.
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