The Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia
Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Other Neuromodulatory Drugs (Toludesvenlafaxine) in the Treatment of Fibromyalgia: A Multicenter Clinical Study
Beijing Tiantan Hospital
384 participants
Oct 20, 2025
INTERVENTIONAL
Conditions
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, 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
Inclusion Criteria7
- 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;
- Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
- Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
- Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.
Exclusion Criteria5
- 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;
- With acute or chronic pain conditions other than FM.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
In the pregabalin monotherapy group, pregabalin will be initiated at 150 mg daily, divided into 2 or 3 doses per day, and increased to 300 mg per day after 3 to 7 days, subsequent increases of 150 mg daily may occur every 3 to 7 days, based on individual patient response and tolerability, with a maximum dose of 600 mg daily.
In the pregabalin with toludesvenlafaxine group, the dose titration of pregabalin is identical with pregabalin monotherapy group. Toludesvenlafaxine will be administered at 40 mg daily initially. If the initial dose is well-tolerated, the dose could be further escalated by 40 mg per day after 7 days, up to a maximum of 160 mg per day. With each dose increase, AEs will be assessed and categorized as mild, moderate, or severe. If participants tolerate the current dose for 2 to 3 days, it will be maintained, with the expectation that tolerance to AEs will develop. If AEs become intolerable, the dose will be decreased back to the previous dose, which was defined as the maximum tolerated dose. In the combination group, dose titration of both pregabalin and toludesvenlafaxine will be conducted simultaneously. If AEs occur, the next dose regimen should be determined in consultation with a clinical physician.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07208357