A Study to Assess the Analgesic Efficacy and Safety of ASP0819 in Patients With Fibromyalgia

Phase 2 Completed 186 enrolled Astellas Pharma Global Development, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This study assessed analgesic efficacy of ASP0819 relative to placebo as well as the safety and tolerability. This study assessed treatment differences in physical function as well as the improvements in overall subject status (e.g., fibromyalgia symptoms and global functioning) of ASP0819 relative to placebo.

Timeline

Start: 2017-03-20
Primary completion: 2018-02-27
Completion: 2018-02-27

Outcome

Missed primary endpoint

paper There was no statistically significant difference between ASP0819 and placebo for the primary endpoint (P=0.086); PMID 33328761 ↗

registry analysis (superiority test); Placebo vs ASP0819 15 mg; p = 0.086; LSMean Difference -0.34 (90% CI -0.76 to 0.07); MMRM NCT03056690 ↗

Publications

Arnold LM, Blauwet MB, Tracy K, Cai N, Walzer M, Blahunka P, Marek GJ. Efficacy and Safety of ASP0819 in Patients with Fibromyalgia: Results of a Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial. J Pain Res. 2020 Dec 10;13:3355-3369. doi: 10.2147/JPR.S274562. eCollection 2020.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP0819	Unknown	15 mg	Oral