Comparing pregabalin and mirogabalin for fibromyalgia pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares pregabalin, a commonly used treatment for fibromyalgia, with mirogabalin, a newer selective α2δ ligand, to see which provides better pain relief and tolerability. Adults newly diagnosed with fibromyalgia by the 2016 criteria, with moderate-to-severe pain (NRS ≥4) and no prior pharmacologic treatment for FM, will be enrolled at multiple hospitals in China. Participants must meet basic liver and kidney function thresholds and will be monitored for changes in pain scores and adverse events during treatment. The goal is to determine whether mirogabalin offers improved efficacy or a better safety profile compared with pregabalin.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Newly diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;\[1\]
* Aged over 18 years old;
* Suffering from moderate to severe FM, refractory to non-pharmacological interventions and without prior exposure to recommend pharmacological treatments for FM;
* Baseline numeric rating scale (NRS) score of 4 or higher;
* Aspartate aminotransferase and alanine aminotransferase levels below twice the upper limit of normal range;
* Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m²;
* Willingness to provide informed consent and adequate cognitive and language capabilities to meet all study requirements;

Exclusion Criteria:

* Previous allergic reactions to pregabalin, mirogabalin, or any of their excipients;
* Prior diagnosis of epilepsy or depression requiring antidepressant therapy;
* Women who are pregnant or breastfeeding;
* Has severe systemic illnesses, such as poorly controlled hypertension, poorly controlled diabetes mellitus, or significant cardiac impairment;
* Suffering from acute or chronic pain disorders other than FM.

Where it's running

• Beijing Tiantan Hospital, Beijing, Beijing 100070
  Beijing, China Recruiting

Study contacts

• Study coordinator: Fang Luo
• Email: 13611326978@163.com
• Phone: +8613611326978

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.