About this trial
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.
Eligibility criteria
Qualifiers
Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
Aged 18 years or older;
Experiencing moderate to severe FM that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
Numeric rating scale (NRS) score ≥ 4 at baseline;
Disqualifiers
History of hypersensitivity to pregabalin, toludesvenlafaxine or any of its excipients;
History of epilepsy, or depression requiring antidepressant medications;
Pregnancy or breastfeeding;
Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac dysfunction;
Trial design
Treatments tested in this trial
- Pregabalin
- Pregabalin with toludesvenlafaxine