Comparing pregabalin and mirogabalin for fibromyalgia pain

Comparing the Efficacy and Safety of Pregabalin Monotherapy Versus Other Neuromodulatory Drugs (Mirogabalin) in the Treatment of Fibromyalgia: A Multicenter Clinical Study

This trial will test whether mirogabalin or pregabalin better reduces pain and causes fewer side effects in adults with moderate-to-severe fibromyalgia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 674 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07157852 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (over 18) newly diagnosed with fibromyalgia per the 2016 criteria, with moderate-to-severe symptoms (NRS ≥4), refractory to non-drug measures, with acceptable liver and kidney function, and no prior recommended pharmacologic treatment for FM.

Not a fit: Patients with prior allergic reactions to either drug, a history of epilepsy or depression requiring antidepressants, pregnancy or breastfeeding, severe uncontrolled systemic illness, or significant hepatic/renal impairment are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, the trial could identify a more effective or better-tolerated medication option to reduce pain in people with fibromyalgia.

How similar studies have performed: Pregabalin has shown modest benefit in prior trials (roughly 25–40% pain relief) but common side effects, while mirogabalin has promising animal and early clinical data but remains unproven for fibromyalgia in larger clinical trials.

Eligibility criteria

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 this trial is running

Beijing

• Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Fang Luo

Conditions Fibromyalgia; Pregabalin; Mirogabalin; Pain