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
Visit trial
Status Recruiting
Results Published No
Start date 10 October 2020
End date 31 August 2024
Phase Not Applicable
Design Blinded
Type Interventional
Generation Second
Participants 210
Sex All
Age 18- 65
Therapy No

Trial Details

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.

NCT Number NCT04436250

Data attribution

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