NCT03092726

A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia

A Phase 2a, Randomized, Double-Blind Placebo-controlled, Parallel-group Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess analgesic efficacy of ASP8062 relative to placebo as well as the safety and tolerability. This study also assessed the treatment differences in physical function as well the improvements in overall subject status (e.g., fibromyalgia symptoms, global functioning) of ASP8062 relative to placebo.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	ASP8062	ASP8062 30 mg was administered orally as a single daily dose, taken preferably in the morning with or without food.
DRUG	Placebo	Placebo was administered orally as a single daily dose, taken preferably in the morning with or without food.

Timeline

• Start date: 2017-05-08
• Primary completion: 2018-03-06
• Completion: 2018-03-06
• First posted: 2017-03-28
• Last updated: 2025-11-03
• Results posted: 2019-03-28

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study