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

Capital Medical University

Status

Enrolling

Conditions

Fibromyalgia

Duloxetine

Pregabalin

Pain

Treatments

Drug: Pregabalin with toludesvenlafaxine

Drug: Pregabalin

Study type

Interventional

Funder types

Other

Identifiers

NCT07208357

KY2025-217-03-05

Details and patient eligibility

About

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.

Enrollment

384 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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 criteria

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.