drugset / Trial / NCT07157852
The Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia
Recruiting
674 enrolled
Beijing Tiantan Hospital
Affiliated Hospital of Yanbian University · collabChongqing Three Gorges Central Hospital · collabThe First Affiliated Hospital of Army Medical University (Southwest Hospital) · collabThe First Affiliated Hospital of Nanchang University · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-09-05
- Primary completion
- 2027-06-30
- Completion
- 2027-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirogabalin | Small molecule | 15 mg | — |
| Comparator | Pregabalin | Small molecule | 450 mg | — |