Treatment of Pain Associated With Fibromyalgia

Recruiting in Palo Alto (17 mi)

+151 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Daiichi Sankyo

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the subject that best describes his or her worst pain over the previous 24 hours.

Research Team

Global Clinical Leader

Principal Investigator

Daiichi Sankyo

Eligibility Criteria

Inclusion Criteria

ADPS of ≥ 4 on the 11-point numeric rating scale (NRS) over the past 7 days prior to randomization (based on completion of at least 4 daily pain diaries during the 7-day baseline period prior to randomization)

Subject must have documented evidence of a fundoscopic examination (with pupil dilation) within 12 months prior to screening or at screening.

Women of child-bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy during the study and for 4 weeks after study completion.

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Treatment Details

Interventions

DS-5565 (Other)
Placebo capsule (Other)
Placebo tablet (Other)
Pregabalin (Other)

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: PregabalinExperimental Treatment2 Interventions

Participants take one pregabalin capsule and one placebo tablet BID

Group II: DS-5565 15 mg QDExperimental Treatment3 Interventions

Participants take one each of placebo tablet and capsule in the morning and one placebo capsule in the evening with one DS-5565 tablet once daily (QD)

Group III: DS-5565 15 mg BIDExperimental Treatment2 Interventions

Participants take one placebo capsule with one DS-5565 tablet BID

Group IV: PlaceboPlacebo Group2 Interventions

Participants take one each of placebo tablet and capsule, twice daily (BID)