Actively Recruiting
The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia
Led by Beijing Tiantan Hospital · Updated on 2026-02-11
1116
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
C
China-Japan Friendship Hospital
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. 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.
CONDITIONS
Official Title
The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with fibromyalgia according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria
- Aged over 18 years old
- Having moderate to severe fibromyalgia not responding to non-drug treatments and no prior use of recommended drug treatments for FM
- Baseline numeric rating scale pain score of 4 or higher
- Liver enzyme levels (aspartate aminotransferase and alanine aminotransferase) below twice the upper normal limit
- Estimated kidney function (eGFR) of at least 30 mL/min/1.73 m²
- Able and willing to provide informed consent and meet study requirements with adequate cognitive and language abilities
You will not qualify if you...
- Previous allergic reactions to pregabalin, crisugabalin, or their ingredients
- Prior diagnosis of epilepsy or depression requiring antidepressant therapy
- Women who are pregnant or breastfeeding
- Having severe systemic illnesses such as uncontrolled high blood pressure, uncontrolled diabetes, or serious heart problems
- Having acute or chronic pain conditions other than 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, M.D.
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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