About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Pregabalin
- Crisugabalin
Treatment groups
Sponsors and collaborators
Beijing Tiantan Hospital
Lead sponsor
China-Japan Friendship Hospital
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Peking University Third Hospital
Collaborator
The Fourth Affiliated Hospital of Harbin Medical University
Collaborator
Zhongnan Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
The Affiliated Hospital of Yanbian University
Collaborator
The Second Hospital University of South China
Collaborator
LanZhou University
Collaborator