drugset / Trial / NCT07230197

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

NCT07230197

Recruiting 400 enrolled Beijing Tiantan Hospital
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. Dexmedetomidine, a highly selective α2-adrenergic receptors agonist, could improve sleep disorders, making it a possible treatment option for treating FM. The investigators hypothesize that the combination of pregabalin with dexmedetomidine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 100 ug Intranasal
Comparator Pregabalin Small molecule 600 mg

Indications