Actively Recruiting
The Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia
Led by Beijing Tiantan Hospital · Updated on 2025-11-17
384
Participants Needed
1
Research Sites
97 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. Selective serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine, has demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Several studies have highlighted benefits of toludesvenlafaxine in FM. We hypothesize that the combination of pregabalin with toludesvenlafaxine 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 Toludesvenlafaxine 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 diagnostic criteria
- Aged 18 years or older
- Experiencing moderate to severe fibromyalgia not relieved by non-drug treatments and not previously treated with recommended fibromyalgia drugs
- Numeric rating scale (NRS) pain score of 4 or higher at the start of the study
- Liver enzyme levels less than twice the upper normal limit
- Kidney function with an estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher
- Able and willing to give informed consent and follow study requirements
You will not qualify if you...
- Allergy or hypersensitivity to pregabalin, toludesvenlafaxine, or their ingredients
- History of epilepsy or depression requiring antidepressant treatment
- Pregnant or breastfeeding
- Serious uncontrolled health problems such as high blood pressure, diabetes, or heart disease
- 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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here