Actively Recruiting
The Efficacy and Safety of Pregabalin Combined With Dexmedetomidine in Patients With Fibromyalgia
Led by Beijing Tiantan Hospital · Updated on 2025-11-28
400
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
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. Dexmedetomidine, a highly selective α2-adrenergic receptors agonist, could improve sleep disorders, making it a possible treatment option for treating FM. The investigators hypothesize that the combination of pregabalin with dexmedetomidine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.
CONDITIONS
Official Title
The Efficacy and Safety of Pregabalin Combined With Dexmedetomidine in Patients With Fibromyalgia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with fibromyalgia according to the 2016 revised diagnostic criteria
- Age 18 years or older
- Moderate to severe fibromyalgia not improved by non-drug treatments
- Has not used currently recommended fibromyalgia medications
- Numeric rating scale pain score of 4 or higher at baseline
- Liver enzyme levels less than twice the normal upper limit
- Kidney function (eGFR) of 30 mL/min/1.73 m2 or higher
- Able and willing to provide informed consent and follow study requirements
You will not qualify if you...
- Allergic to pregabalin, venlafaxine, or their ingredients
- History of epilepsy or depression needing antidepressants
- Pregnant or breastfeeding
- Serious health problems like uncontrolled high blood pressure, diabetes, or 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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