An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia

Pain Associated With Fibromyalgia Clinical Trial

Official title:
An Open-label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia

Status Completed

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

Fibromyalgia
Myofascial Pain Syndromes
Pain Associated With Fibromyalgia

Clinical Trial Details

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

View Details

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)