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

Capital Medical University

Status

Enrolling

Conditions

Fibromyalgia

Pregabalin

Pain

Treatments

Drug: Pregabalin

Drug: Crisugabalin

Study type

Interventional

Funder types

Other

Identifiers

NCT07196657

KY2025-217-03-02

Details and patient eligibility

About

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. crisugabalin, 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 crisugabalin in treating FM, with the aim of providing a better treatment option for FM patients.

Enrollment

1,116 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
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, crisugabalin, 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.