drugset / Trial / NCT07171320

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

NCT07171320

RandomizedParallel-groupOpen-labelTreatment

Summary

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 and venlafaxine, have demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Desvenlafaxine, the third SNRI, was found with lower adverse effects compared with duloxetine and venlafaxine. We hypothesize that the combination of pregabalin with desvenlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.

Timeline

Start
2025-09-15
Primary completion
2027-06-30
Completion
2027-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Desvenlafaxine Other / unclassified 400 mg
Background Pregabalin Small molecule 600 mg

Indications