DS-5565 for 52 weeks in pain associated with fibromyalgia (FM)
Research type
Research Study
Full title
An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated with Fibromyalgia
IRAS ID
163963
Contact name
Anthony Jones
Contact email
Sponsor organisation
Daiichi Sankyo Development Ltd
Eudract number
2013-005164-26
Clinicaltrials.gov Identifier
118,304, IND Number
Duration of Study in the UK
1 years, 9 months, 30 days
Research summary
The main purpose of this study is to collect information about a new drug called DS5565 that may help participants who have pain associated with Fibromyalgia. Fibromyalgia is a disease characterised by persistent muscle pain, fatigue, and some sensitive painful parts in the body, it is also associated with sleep problems, fatigue, depression, and anxiety.
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 FM (DS5565-A-E311) or subjects who did not participate in a preceeding double-blind study (referred to as 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.
For rollover subjects, the total study duration (for an individual subject’s participation) will be approximately 56 weeks, including 52 weeks of open-label treatment and 4 weeks of post-treatment follow-up. De novo subjects will also have a screening/baseline period of up to 3 weeks and therefore a total duration of approximately 59 weeks.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/1374
Date of REC Opinion
19 Dec 2014
REC opinion
Further Information Favourable Opinion