The Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia

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.

NCT Number	NCT07208357
Lead Sponsor	Beijing Tiantan Hospital
Conditions	Fibromyalgia, Pregabalin, Duloxetine, Pain
Enrollment	384 participants
Start Date	2025-10-20
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-11-17