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ESKETamine for FIBromyalgia Treatment (ESKEFIB)

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Active comparator
S-Ketamine Low dose
S-Ketamine High dose
Sponsored by
Grand Hôpital de Charleroi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fibromyalgia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grand Hôpital de CharleroiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Placebo

S-Ketamine Low dose

S-ketamine High dose

Arm Description

Clonidine at a dose of 1 microg/kg Magnesium sulfate at a dose of 40 mg/kg

S-Ketamine at a dose of 0.2 mg/kg

S-ketamine at a dose of 0.4 mg/kg

Outcomes

Primary Outcome Measures

The primary outcome is twofold, aiming on one side pain relief and on the other the improvement of the patient's functional status
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

Number of patients showing 50 % reduction in the BPI (Brief Pain Inventory) pain index
Measures will be done with different questionnaires

Full Information

First Posted
June 15, 2020
Last Updated
September 11, 2023
Sponsor
Grand Hôpital de Charleroi
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1. Study Identification

Unique Protocol Identification Number
NCT04436250
Brief Title
ESKETamine for FIBromyalgia Treatment
Acronym
ESKEFIB
Official Title
Intravenous Infusions of S-KETAMINE in Fibromyalgia Syndromes: an Exploratory Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grand Hôpital de Charleroi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Clonidine at a dose of 1 microg/kg Magnesium sulfate at a dose of 40 mg/kg
Arm Title
S-Ketamine Low dose
Arm Type
Experimental
Arm Description
S-Ketamine at a dose of 0.2 mg/kg
Arm Title
S-ketamine High dose
Arm Type
Experimental
Arm Description
S-ketamine at a dose of 0.4 mg/kg
Intervention Type
Drug
Intervention Name(s)
Active comparator
Intervention Description
The active comparator is composed of clonidine 1 microg/kg combined with magnesium sulfate 40 mg/kg diluted in 45 ml of sodium chloride
Intervention Type
Drug
Intervention Name(s)
S-Ketamine Low dose
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
S-Ketamine High dose
Intervention Description
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 Measure Information:
Title
The primary outcome is twofold, aiming on one side pain relief and on the other the improvement of the patient's functional status
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of patients showing 50 % reduction in the BPI (Brief Pain Inventory) pain index
Description
Measures will be done with different questionnaires
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Paul Lechat, MD
Phone
00 32 71 10
Ext
4071
Email
jean-paul.lechat@ghdc.be
First Name & Middle Initial & Last Name or Official Title & Degree
Zuzana Javorcikova, MD
Phone
00 32 474 64
Ext
1109
Email
z.javorcikova.pro@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Lechat, MD
Organizational Affiliation
Grand Hôpital de Charleroi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grand Hôpital de Charleroi
City
Gilly
State/Province
Hainaut
ZIP/Postal Code
6060
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Paul Lechat, MD
Phone
00 32 71 10
Ext
4071
Email
jean-paul@ghdc.be
First Name & Middle Initial & Last Name & Degree
Zuzana Javorcikova, MD
Phone
00 32 474 64
Ext
1109
Email
z.javorcikova.pro@gmail.com
First Name & Middle Initial & Last Name & Degree
Philippe Van der Linden, MD, PhD
First Name & Middle Initial & Last Name & Degree
Michel Dangoisse, MD
First Name & Middle Initial & Last Name & Degree
Stéphane Nikis, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34838114
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.
Results Reference
derived

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ESKETamine for FIBromyalgia Treatment

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