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Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Other Neuromodulatory Drugs (Venlafaxine) in the Treatment of Fibromyalgia: A Multicenter Clinical Study
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 venlafaxine in FM. We hypothesize that the combination of pregabalin with venlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijin, China
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China
Start Date
September 20, 2025
Primary Completion Date
June 30, 2027
Completion Date
August 31, 2027
Last Updated
January 15, 2026
750
ESTIMATED participants
Pregabalin
DRUG
Pregabalin with venlafaxine
DRUG
Lead Sponsor
Beijing Tiantan Hospital
Collaborators
NCT05901259
NCT03759522
Data Source & Attribution
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