ESKETamine for FIBromyalgia Treatment

This interventional trial (n=210) aims to explore the efficacy of intravenous infusions of esketamine (14-21mg/70kg) in fibromyalgia syndromes.

Fibromyalgia, characterised by chronic pain, lacks a complete cure, with available treatments mainly focusing on pain relief and improving the quality of life. The study, conducted by Grand Hôpital de Charleroi in Belgium, seeks to investigate the potential of esketamine, an antagonist to the N-methyl-D-aspartate receptor, in alleviating fibromyalgia symptoms.

Participants, aged 18-65 years, suffering from chronic pain diagnosed as fibromyalgia, will be enrolled. The trial involves three arms: placebo, esketamine Low dose (0.2 mg/kg), and esketamine High dose (0.4 mg/kg). Patients will be randomly assigned in a 2:1 ratio to receive either esketamine or placebo.

The primary outcome measures are pain relief, evaluated by a two-point decrease on the Brief Pain Inventory (BPI) pain severity index at twelve weeks follow-up, and improvement in functional status, assessed by a one-point reduction on the BPI Interference scale.

Secondary outcome measures include the number of patients showing a 50% reduction in the BPI pain index. Recruitment for this trial started on October 10, 2020, and is estimated to complete by August 2024.

Topic Fibromyalgia
Compound Placebo Ketamine
Country Belgium
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