Actively Recruiting
The Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia
Led by Beijing Tiantan Hospital · Updated on 2026-03-04
674
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
S
Second Affiliated Hospital of Nanchang University
Collaborating Sponsor
AI-Summary
What this Trial Is 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. 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.
CONDITIONS
Official Title
The Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed with fibromyalgia according to the 2016 revisions to the 2010/2011 FM diagnostic criteria
- Aged over 18 years old
- Moderate to severe fibromyalgia not improved by non-drug treatments and no prior recommended drug treatments
- Baseline numeric rating scale pain score of 4 or higher
- Liver enzymes (AST and ALT) less than twice the upper limit of normal
- Estimated kidney filtration rate (eGFR) of at least 30 mL/min/1.73 m²
- Ability and willingness to provide informed consent and meet study requirements
You will not qualify if you...
- Previous allergic reactions to pregabalin, mirogabalin, or their ingredients
- History of epilepsy or depression needing antidepressant treatment
- Pregnant or breastfeeding women
- Severe health problems such as poorly controlled high blood pressure, diabetes, or major heart issues
- Having other acute or chronic pain conditions besides fibromyalgia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China
Actively Recruiting
Research Team
F
Fang Luo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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