The Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia

Phase

N/A

Condition

Fibromyalgia

Pain

Treatment

Mirogabalin

Pregabalin

Clinical Study ID

NCT07157852

KY2025-217-03-01

Ages > 18
All Genders

Study Summary

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Mirogabalin, a new highly selective α2δ ligand, has shown potential in animal models or preliminary clinical trials, but there is insufficient evidence for its application in FM. This study aims to explore the effectiveness and safety of pregabalin or mirogabalin in treating FM, with the aim of providing a better treatment option for FM patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Newly diagnosed with FM according to the 2016 Revisions to the 2010/2011 FMdiagnostic criteria;[1]
Aged over 18 years old;
Suffering from moderate to severe FM, refractory to non-pharmacologicalinterventions and without prior exposure to recommend pharmacological treatments forFM;
Baseline numeric rating scale (NRS) score of 4 or higher;
Aspartate aminotransferase and alanine aminotransferase levels below twice the upperlimit 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 languagecapabilities to meet all study requirements;

Exclusion

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, poorlycontrolled diabetes mellitus, or significant cardiac impairment;
Suffering from acute or chronic pain disorders other than FM.

Study Design