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

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.

NCT Number	NCT07196657
Lead Sponsor	Beijing Tiantan Hospital Collaborators: China-Japan Friendship Hospital, The First Affiliated Hospital of Nanchang University, Peking University Third Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Zhongnan Hospital, Xiangya Hospital of Central South University, The Affiliated Hospital of Yanbian University, The Second Hospital University of South China, LanZhou University
Conditions	Fibromyalgia, Pregabalin, Pain
Enrollment	1,116 participants
Start Date	2025-09-30
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-11