Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

ESKETamine for FIBromyalgia Treatment (ESKEFIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436250
Recruitment Status : Not yet recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Grand Hôpital de Charleroi

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Active comparator Drug: S-Ketamine Low dose Drug: S-Ketamine High dose Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Patients will be randomized in a 2:1 ratio (S-ketamine : placebo) 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).

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The research pharmacist prepares the syringe with a placebo or active drug (group 1 with 0.2mg/kg or group 2 with 0.4 mg/kg of S-Ketamine) and anonymizes it before giving it to care provider.
Primary Purpose: Supportive Care
Official Title: Intravenous Infusions of S-KETAMINE in Fibromyalgia Syndromes: an Exploratory Study.
Estimated Study Start Date : June 25, 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Placebo
Clonidine at a dose of 1 microg/kg Magnesium sulfate at a dose of 40 mg/kg
Drug: Active comparator
The active comparator is composed of clonidine 1 microg/kg combined with magnesium sulfate 40 mg/kg diluted in 45 ml of sodium chloride

Experimental: S-Ketamine Low dose
S-Ketamine at a dose of 0.2 mg/kg
Drug: Active comparator
The active comparator is composed of clonidine 1 microg/kg combined with magnesium sulfate 40 mg/kg diluted in 45 ml of sodium chloride

Drug: S-Ketamine Low dose
The arm 1 is composed of esketamine 0.2 mg/kg and clonidine 1 microg/kg combined with magnesium sulfate 40 mg/kg diluted in 45 ml of sodium chloride.

Experimental: S-ketamine High dose
S-ketamine at a dose of 0.4 mg/kg
Drug: Active comparator
The active comparator is composed of clonidine 1 microg/kg combined with magnesium sulfate 40 mg/kg diluted in 45 ml of sodium chloride

Drug: S-Ketamine High dose
The arm 2 is composed of esketamine 0.4 mg/kg and clonidine 1 microg/kg combined with magnesium sulfate 40 mg/kg diluted in 45 ml of sodium chloride.




Primary Outcome Measures :
  1. The primary outcome is twofold, aiming on one side pain relief and on the other the improvement of the patient's functional status [ Time Frame: 12 weeks ]

    Pain relief will be considered as a two point decrease on the Brief Pain Inventory (BPI) pain severity index at twelve weeks follow-up. (Two points being established as the Minimal Clinically Important Difference (MCID) for fibromyalgic patients).

    The functional status will be evaluated by the BPI Interference scale. An improvement will be considered as a one point reduction on this index (as established by the MCID).

    The primary outcome is to determine whether the association of S-ketamine to the analgesic treatment will increase the number of patients showing a clinically significant improvement of pain and/or functional status.



Secondary Outcome Measures :
  1. Number of patients showing 50 % reduction in the BPI (Brief Pain Inventory) pain index [ Time Frame: 12 weeks ]
    Measures will be done with different questionnaires



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436250


Contacts
Layout table for location contacts
Contact: Jean-Paul Lechat, MD 00 32 71 10 ext 4071 jean-paul.lechat@ghdc.be
Contact: Zuzana Javorcikova, MD 00 32 474 64 ext 1109 z.javorcikova.pro@gmail.com

Locations
Layout table for location information
Belgium
Grand Hôpital de Charleroi
Gilly, Hainaut, Belgium, 6060
Contact: Jean-Paul Lechat, MD    00 32 71 10 ext 4071    jean-paul@ghdc.be   
Contact: Zuzana Javorcikova, MD    00 32 474 64 ext 1109    z.javorcikova.pro@gmail.com   
Sub-Investigator: Philippe Van der Linden, MD, PhD         
Sub-Investigator: Michel Dangoisse, MD         
Sub-Investigator: Stéphane Nikis, MD         
Sponsors and Collaborators
Grand Hôpital de Charleroi
Investigators
Layout table for investigator information
Principal Investigator: Jean-Paul Lechat, MD Grand Hôpital de Charleroi
Layout table for additonal information
Responsible Party: Grand Hôpital de Charleroi
ClinicalTrials.gov Identifier: NCT04436250    
Other Study ID Numbers: ESKEFIB
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Ketamine
Esketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents
Psychotropic Drugs