drugset / Trial / NCT04436250

ESKETamine for FIBromyalgia Treatment

NCT04436250

Terminated 23 enrolled Grand Hôpital de Charleroi
RandomizedSequentialTriple-blindSupportive care

Summary

Fibromyalgia is a cause of chronic pain, classified by the Internal Classification of Diseases (ICD) as a primary chronic pain with specific diagnostic criteria established by the American College of Rheumatology (ACR). No treatment to its complete cure is available at this time, all treatments having as purpose pain relief and an improvement of quality of life by combining pharmacologic and nonpharmacologic treatments. One of the mechanisms proposed in fibromyalgia is the central sensitisation phenomenon, by which the central nervous system becomes "hypersensitive" to nociceptive or non-nociceptive stimuli. The receptor involved in this phenomenon is the N-methyl-D-aspartate receptor to which ketamine binds. Ketamine has therefore been proposed as a co-treatment in chronic pain with central sensitization phenomena, such as fibromyalgia.

Timeline

Start
2020-10-10
Primary completion
2024-08-31
Completion
2024-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified 0.2 mg/kg Intravenous
Subject Esketamine Other / unclassified 0.4 mg/kg Intravenous
Background Clonidine Other / unclassified 1 ug/kg
Background Magnesium Sulfate Other / unclassified 40 mg/kg

Indications