drugset / Trial / NCT07230171

The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia

NCT07230171

RandomizedParallel-groupOpen-labelTreatment

Summary

Fibromyalgia is a chronic pain syndrome where current medications have limited efficacy and a slow onset of action. Esketamine shows potential as a rapid-acting analgesic, but previous low-dose studies failed to demonstrate long-term benefits. The efficacy of higher-dose ESK as an adjunctive therapy when standard treatments are insufficient remains unclear.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified 1 mg/kg Intravenous
Comparator Pregabalin Small molecule 450 mg Oral
Comparator Venlafaxine Small molecule 225 mg Oral

Indications