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Mirogabalin is non-inferior or superior to pregabalin in reducing pain in Asian patients with fibromyalgia

This is a protocol for a prospective, multicentre, randomised, open-label, blinded endpoint (PROBE) trial comparing mirogabalin with pregabalin in 674 adult fibromyalgia patients with moderate-to-severe pain. The primary outcome is the proportion of patients achieving at least 50% pain reduction at 12 weeks. The study aims to provide evidence on mirogabalin's efficacy and safety in an Asian fibromyalgia population, where direct comparisons are lacking.

Last updated: Aug 27, 2026โ€ข1 RCTsโ€ข๐Ÿ“– Read as article โ†’

Evidence Score

Evidence Score44/100
Human RCTโ˜…โ˜…โ˜†โ˜†โ˜†
Meta-analysisโ˜†โ˜†โ˜†โ˜†โ˜†
Mechanismโ˜…โ˜…โ˜…โ˜…โ˜…
Safetyโ˜…โ˜…โ˜…โ˜…โ˜†
Confidencelow

Study Evidence

Study 1. Efficacy and safety of mirogabalin in patients with fibromyalgia: protocol for a multicentre, Prospective, Randomised, Open-label, Blinded Endpoint (PROBE) study.

observational

Liu M, Li Y, Yao X, Liang Y, Mao P, Huang Y, Zhang C, Li Y, Li C, Ma K, Li S, Zhang D, Luo F, Fan B ยท BMJ open (2026)

Participants: N/A
Duration: 12 weeks
Intervention: Mirogabalin with individualised dose titration, compared to pregabalin with individualised dose titration
Outcome: Proportion of patients with โ‰ฅ50% pain reduction at 12 weeks; secondary outcomes include average pain intensity, worst pain intensity, Revised FM Impact Questionnaire, Brief Pain Inventory, SF-36, Medical Outcomes Study Sleep Scale, Beck Depression Inventory-II, and adverse events
Effect Size: N/A (protocol paper, no results yet)
Population: Adults over 18 years diagnosed with fibromyalgia according to 2016 revisions to 2010/2011 criteria, with moderate-to-severe pain, from five Chinese hospitals

Result:

PubMed: 42642082DOI: 10.1136/bmjopen-2025-110911

Mechanism Graph

Mirogabalin binds to ฮฑ2ฮด subunits of voltage-gated calcium channels
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This binding reduces calcium influx and neurotransmitter release
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Modulation of pain signaling pathways leads to analgesic effects
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Result: Potential pain reduction in fibromyalgia patients

Limitations

  • โš Open-label design may introduce bias despite blinded endpoint assessment
  • โš No results yet; protocol paper only, so efficacy and safety claims are not yet confirmed
  • โš Limited to Asian population, may not generalise to other ethnic groups

Frequently Asked Questions

What is the primary outcome of this mirogabalin trial?โ–ผ

The primary outcome is the proportion of patients achieving at least 50% pain reduction at 12 weeks.

How many patients are enrolled in this study?โ–ผ

674 qualified patients with moderate-to-severe fibromyalgia are randomly assigned to either mirogabalin or pregabalin in a 1:1 ratio.

What is the study design?โ–ผ

It is a prospective, multicentre, randomised, open-label, blinded endpoint (PROBE) trial.

Why is this study needed?โ–ผ

There is limited data on mirogabalin for fibromyalgia, and no direct comparison with pregabalin in an Asian fibromyalgia population.

Products

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References

  1. 1.Liu M, Li Y, Yao X, Liang Y, Mao P, Huang Y, Zhang C, Li Y, Li C, Ma K, Li S, Zhang D, Luo F, Fan B. "Efficacy and safety of mirogabalin in patients with fibromyalgia: protocol for a multicentre, Prospective, Randomised, Open-label, Blinded Endpoint (PROBE) study.." BMJ open, 2026. PMID: 42642082 DOI: 10.1136/bmjopen-2025-110911
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.