Clinical trial NCT04436250: ESKETamine for FIBromyalgia Treatment
Official title: Intravenous Infusions of S-KETAMINE in Fibromyalgia Syndromes: an Exploratory Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Grand Hôpital de Charleroi
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Patients will be randomized in a 2:1 ratio (S-ketamine : placebo) per block of 15 patients sequentially into the first 2 groups, one with placebo and one with first dose of S-Ketamine Low Dose (0.2mg/kg).

A second group will receive S-Ketamine High Dose (0.4 mg/kg) with the same randomized ratio (2:1).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Ketamine is a drug used for anesthesia since the 1970s, acting as an antagonist to the N-methyl-D-aspartate receptor located in the central nervous system. It has two stereoisomers : R +ketamine and S - ketamine, the latter being about two to four times more potent. S-ketamine also has the advantages of producing less psychotropic effects, less tiredness and a lower temporary cognitive impairment than the racemic mixture at equianalgesic doses. Being first used as an anesthetic, in the last twenty years, ketamine's indications expanded to other domains, such as treatment of depression or off label use for chronic pain relief. Chronic pain is a multidimensional syndrome that touches 17-44% of the population of western countries. 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 (as given by the European League Against Rheumatism (EULAR) guidelines). 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.

Eligibility criteria: Inclusion Criteria:

* patients suffering from chronic pain (as defined by International Association for the Study of Pain) being diagnosed as fibromyalgia according to the American College of Rheumatology 2016 criteria
* patients qualified for the treatment by S-ketamine as established by our latest clinical practice
* patients aged 18-65 years old

Primary outcomes:
measure: The primary outcome is twofold, aiming on one side pain relief and on the other the improvement of the patient's functional status
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of patients showing 50 % reduction in the BPI (Brief Pain Inventory) pain index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gilly
country: Belgium
facility: Grand Hôpital de Charleroi
state: Hainaut
Study officials:
affiliation: Grand Hôpital de Charleroi
name: Jean-Paul Lechat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Javorcikova Z, Dangoisse M, Nikis S, Lechat JP, Gillain A, Fils JF, Van der Linden P. The place of S-ketamine in fibromyalgia treatment (ESKEFIB): study protocol for a prospective, single-center, double-blind, randomized, parallel-group, dose-escalation controlled trial. Trials. 2021 Nov 27;22(1):853. doi: 10.1186/s13063-021-05814-4.