Treatment of Pain Associated With Fibromyalgia

Phase 3 Completed 1293 enrolled Daiichi Sankyo Syneos Health · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2014-10-27
Primary completion: 2016-07-14
Completion: 2016-07-14

Outcome

Missed primary endpoint

paper Neither mirogabalin dose demonstrated a significant ADPS reduction from baseline vs. placebo at week 13 in any of the three studies. PMID 31284771 ↗

registry analysis (superiority test); Placebo vs DS-5565 15 mg QD; p = 0.0944; Mean Difference (Final Values) -0.31 (95% CI -0.67 to 0.05); Difference of means NCT02146430 ↗

registry analysis (superiority test); Placebo vs DS-5565 15 mg BID; p = 0.1391; Mean Difference (Final Values) -0.28 (95% CI -0.64 to 0.09); Difference of means NCT02146430 ↗

Publications

Arnold LM, Whitaker S, Hsu C, Jacobs D, Merante D. Efficacy and safety of mirogabalin for the treatment of fibromyalgia: results from three 13-week randomized, double-blind, placebo- and active-controlled, parallel-group studies and a 52-week open-label extension study. Curr Med Res Opin. 2019 Oct;35(10):1825-1835. doi: 10.1080/03007995.2019.1629757. Epub 2019 Jul 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirogabalin	Small molecule	15 mg	Oral
Comparator	Pregabalin	Small molecule	150 mg	Oral