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ESKETamine for FIBromyalgia Treatment (ESKEFIB)

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ClinicalTrials.gov Identifier: NCT04436250
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Grand Hôpital de Charleroi

Tracking Information
First Submitted Date  ICMJE June 15, 2020
First Posted Date  ICMJE June 18, 2020
Last Update Posted Date July 20, 2021
Actual Study Start Date  ICMJE October 10, 2020
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ESKETamine for FIBromyalgia Treatment
Official Title  ICMJE Intravenous Infusions of S-KETAMINE in Fibromyalgia Syndromes: an Exploratory Study.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
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).

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
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Placebo
    Clonidine at a dose of 1 microg/kg Magnesium sulfate at a dose of 40 mg/kg
    Intervention: Drug: Active comparator
  • Experimental: S-Ketamine Low dose
    S-Ketamine at a dose of 0.2 mg/kg
    Interventions:
    • Drug: Active comparator
    • Drug: S-Ketamine Low dose
  • Experimental: S-ketamine High dose
    S-ketamine at a dose of 0.4 mg/kg
    Interventions:
    • Drug: Active comparator
    • Drug: S-Ketamine High dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2020)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04436250
Other Study ID Numbers  ICMJE ESKEFIB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grand Hôpital de Charleroi
Study Sponsor  ICMJE Grand Hôpital de Charleroi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Paul Lechat, MD Grand Hôpital de Charleroi
PRS Account Grand Hôpital de Charleroi
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP