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History of Changes for Study: NCT04938713
Comparison of Ketamine and Esketamine in Patients Suffering From Fibromyalgia Syndrome. (KESK-FIQ)
Latest version (submitted August 26, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 17, 2021 None (earliest Version on record)
2 August 26, 2021 Recruitment Status, Study Status and Contacts/Locations
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Study NCT04938713
Submitted Date:  June 17, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: KESK-FIQ
Brief Title: Comparison of Ketamine and Esketamine in Patients Suffering From Fibromyalgia Syndrome. (KESK-FIQ)
Official Title: Comparison of Ketamine and Esketamine in Ambulatory Patients Treated for Fibromyalgia Syndrome in Pain Clinic. A Single-center, Prospective, Randomized, Double-blind, Crossover Study.
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2021
Overall Status: Not yet recruiting
Study Start: July 1, 2021
Primary Completion: May 1, 2022 [Anticipated]
Study Completion: September 30, 2022 [Anticipated]
First Submitted: June 17, 2021
First Submitted that
Met QC Criteria:
June 17, 2021
First Posted: June 24, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
June 17, 2021
Last Update Posted: June 24, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Centre Hospitalier Universitaire de Charleroi
Responsible Party: Principal Investigator
Investigator: Brice Constant, MD
Official Title: MD
Affiliation: Centre Hospitalier Universitaire de Charleroi
Collaborators: Centre Hospitalier Universitaire de Liege
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Ketamine and Esketamine intravenous perfusions can modulate chronic pain. The purpose of this study is to determine if Ketamine or Esketamine are favorable for outpatients suffering from fibromyalgia.
Detailed Description:

Ketamine and Esketamine intravenous perfusions in Pain Clinic can modulate chronic pain and are therefore part of the therapeutic arsenal of the Anesthesiologist in pain management. Patients with fibromyalgia syndrome have elevated levels of glutamate in the brain. This is demonstrated by functional brain imaging techniques. Elevation of glutamate is demonstrated in the posterior insular cortex, positively correlating with lower pain thresholds which is a hallmark of fibromyalgia syndrome. Ketamine has (e.a.) an inhibitory role of the N-methyl-D-aspartate (NMDA) receptor: it is a non-competitive antagonist of the NMDA receptor. In this context, Esketamine is available recently. This is the levorotatory form of Ketamine.

The main objective of this study is to measure if there is a difference between Ketamine and Esketamine on patients with fibromyalgia syndrome via the fibromyalgia impact questionnaire (FIQ) and measurement of side effects after intravenous perfusion. The fibromyalgia impact questionnaire is a global assessment of symptoms: pain, function, fatigue, stiffness, discomfort when walking up stairs, difficulties at work, anxiety, depression, days not worked and days of good quality in the past week.

Open or close this module Conditions
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Ketamine
Esketamine
Fibromyalgia Impact Questionnaire
Side effects
Chronic pain
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 50 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: AB group

If A = Ketamine and B = Esketamine, each patient included in the study will be randomized in a sequence of administration of the two products. The AB sequence consists of patients starting with intravenous Ketamine 0,3 mg/kg in 1 hour (2 infusions separated by 6 weeks; Period 1) and continuing with intravenous Esketamine 0,15 mg/kg in 1 hour (2 infusions separated by 6 weeks; Period 2). Each patient will be monitored during the IV perfusion, and then, the next hour.

The patient will receive a total of two infusions of Ketamine and two infusions of Esketamine. Each patient will be his own witness because having received the two products without knowing which he started with. A "wash-out" period of one week will be observed between the two administration periods to avoid so-called "carry-over" effects according to which the administration of the first drug could influence the effect of the second drug administered.

Drug: Ketamine 50 MG/ML
Intravenous Ketalar® 0,30 mg/kg in 1 hour.
Drug: Esketamine 25 MG/ML
Intravenous Vesierra® 0,15mg/kg in 1 hour.
BA group

If A = Ketamine and B = Esketamine, each patient included in the study will be randomized in a sequence of administration of the two products. The BA sequence consists of patients starting with intravenous Esketamine 0,15 mg/kg in 1 hour (2 infusions separated by 6 weeks; Period 1) and continuing with intravenous Ketamine 0,3 mg/kg in 1 hour (2 infusions separated by 6 weeks; Period 2). Each patient will be monitored during the IV perfusion, and then, the next hour.

The patient will receive a total of two infusions of Esketamine and then two infusions of Ketamine. Each patient will be his own witness because having received the two products without knowing which he started with. A "wash-out" period of one week will be observed between the two administration periods to avoid so-called "carry-over" effects according to which the administration of the first drug could influence the effect of the second drug administered.

Drug: Ketamine 50 MG/ML
Intravenous Ketalar® 0,30 mg/kg in 1 hour.
Drug: Esketamine 25 MG/ML
Intravenous Vesierra® 0,15mg/kg in 1 hour.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Score variations of Fibromyalgia Impact Questionnaire
[ Time Frame: At day 0 before starting each intravenous perfusion. ]

Fibromyalgia Impact Questionnaire (FIQ) completed by the patient. The FIQ was developed from information gathered from patient reports, functional status instruments, and clinical observations. This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week. The score is between 0 and 100. In the severity analysis a FIQ total score from 0 to < 39 was found to represent a mild effect, ≥ 39 to < 59 a moderate effect, and ≥ 59 to 100 a severe effect.
2. Score variations of Fibromyalgia Impact Questionnaire
[ Time Frame: At day 7 after each intravenous perfusion. ]

Fibromyalgia Impact Questionnaire (FIQ) completed by the patient. The FIQ was developed from information gathered from patient reports, functional status instruments, and clinical observations. This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week. The score is between 0 and 100. In the severity analysis a FIQ total score from 0 to < 39 was found to represent a mild effect, ≥ 39 to < 59 a moderate effect, and ≥ 59 to 100 a severe effect.
3. Score variations of Fibromyalgia Impact Questionnaire
[ Time Frame: At day 14 after each intravenous perfusion. ]

Fibromyalgia Impact Questionnaire (FIQ) completed by the patient. The FIQ was developed from information gathered from patient reports, functional status instruments, and clinical observations. This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week. The score is between 0 and 100. In the severity analysis a FIQ total score from 0 to < 39 was found to represent a mild effect, ≥ 39 to < 59 a moderate effect, and ≥ 59 to 100 a severe effect.
4. Score variations of Fibromyalgia Impact Questionnaire
[ Time Frame: At day 21 after each intravenous perfusion. ]

Fibromyalgia Impact Questionnaire (FIQ) completed by the patient. The FIQ was developed from information gathered from patient reports, functional status instruments, and clinical observations. This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week. The score is between 0 and 100. In the severity analysis a FIQ total score from 0 to < 39 was found to represent a mild effect, ≥ 39 to < 59 a moderate effect, and ≥ 59 to 100 a severe effect.
5. Score variations of Fibromyalgia Impact Questionnaire
[ Time Frame: At day 28 after each intravenous perfusion. ]

Fibromyalgia Impact Questionnaire (FIQ) completed by the patient. The FIQ was developed from information gathered from patient reports, functional status instruments, and clinical observations. This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week. The score is between 0 and 100. In the severity analysis a FIQ total score from 0 to < 39 was found to represent a mild effect, ≥ 39 to < 59 a moderate effect, and ≥ 59 to 100 a severe effect.
Secondary Outcome Measures:
1. Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
[ Time Frame: At the beginning (minute zero) of each intravenous perfusion. ]

Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
2. Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
[ Time Frame: After 30 minutes of each intravenous perfusion. ]

Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
3. Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
[ Time Frame: After 60 minutes of each intravenous perfusion. ]

Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
4. Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
[ Time Frame: After 90 minutes of each intravenous perfusion. ]

Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
5. Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
[ Time Frame: After 120 minutes of each intravenous perfusion. ]

Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
6. Variations of Visual Analogue Scale for pain.
[ Time Frame: At the beginning (minute zero) of each intravenous perfusion. ]

Measurement of Visual Analogue Scale (VAS) for pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
7. Variations of Visual Analogue Scale for pain.
[ Time Frame: After 30 minutes of each intravenous perfusion. ]

Measurement of Visual Analogue Scale (VAS) for pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
8. Variations of Visual Analogue Scale for pain.
[ Time Frame: After 60 minutes of each intravenous perfusion. ]

Measurement of Visual Analogue Scale (VAS) for pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
9. Variations of Visual Analogue Scale for pain.
[ Time Frame: After 90 minutes of each intravenous perfusion. ]

Measurement of Visual Analogue Scale (VAS) for pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
10. Variations of Visual Analogue Scale for pain.
[ Time Frame: After 120 minutes of each intravenous perfusion. ]

Measurement of Visual Analogue Scale (VAS) for pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
11. Variations of Visual Analogue Scale for nausea.
[ Time Frame: At the beginning (minute zero) of each intravenous perfusion. ]

Measurement of Visual Analogue Scale (VAS) for nausea. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no nausea" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater nausea.
12. Variations of Visual Analogue Scale for nausea.
[ Time Frame: After 30 minutes of each intravenous perfusion. ]

Measurement of Visual Analogue Scale (VAS) for nausea. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no nausea" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater nausea.
13. Variations of Visual Analogue Scale for nausea.
[ Time Frame: After 60 minutes of each intravenous perfusion. ]

Measurement of Visual Analogue Scale (VAS) for nausea. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no nausea" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater nausea.
14. Variations of Visual Analogue Scale for nausea.
[ Time Frame: After 90 minutes of each intravenous perfusion. ]

Measurement of Visual Analogue Scale (VAS) for nausea. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no nausea" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater nausea.
15. Variations of Visual Analogue Scale for nausea.
[ Time Frame: After 120 minutes of each intravenous perfusion. ]

Measurement of Visual Analogue Scale (VAS) for nausea. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no nausea" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater nausea.
16. Variations of non-invasive blood pressure.
[ Time Frame: At the beginning (minute zero) of each intravenous perfusion. ]

Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
17. Variations of non-invasive blood pressure.
[ Time Frame: After 30 minutes of each intravenous perfusion. ]

Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
18. Variations of non-invasive blood pressure.
[ Time Frame: After 60 minutes of each intravenous perfusion. ]

Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
19. Variations of non-invasive blood pressure.
[ Time Frame: After 90 minutes of each intravenous perfusion. ]

Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
20. Variations of non-invasive blood pressure.
[ Time Frame: After 120 minutes of each intravenous perfusion. ]

Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
21. Variations of pulse Oxygen saturation.
[ Time Frame: At the beginning (minute zero) of each intravenous perfusion. ]

Measurement of variations of pulse Oxygen saturation (SpO2). Pulse oximetry is a non-invasive measures of oxygen saturation level in %. A normal SpO2 is typically between 95 and 100 percent. A SpO2 < 95 percent is considered low.
22. Variations of pulse Oxygen saturation.
[ Time Frame: After 30 minutes of each intravenous perfusion. ]

Measurement of variations of pulse Oxygen saturation (SpO2). Pulse oximetry is a non-invasive measures of oxygen saturation level in %. A normal SpO2 is typically between 95 and 100 percent. A SpO2 < 95 percent is considered low.
23. Variations of pulse Oxygen saturation.
[ Time Frame: After 60 minutes of each intravenous perfusion. ]

Measurement of variations of pulse Oxygen saturation (SpO2). Pulse oximetry is a non-invasive measures of oxygen saturation level in %. A normal SpO2 is typically between 95 and 100 percent. A SpO2 < 95 percent is considered low.
24. Variations of pulse Oxygen saturation.
[ Time Frame: After 90 minutes of each intravenous perfusion. ]

Measurement of variations of pulse Oxygen saturation (SpO2). Pulse oximetry is a non-invasive measures of oxygen saturation level in %. A normal SpO2 is typically between 95 and 100 percent. A SpO2 < 95 percent is considered low.
25. Variations of pulse Oxygen saturation.
[ Time Frame: After 120 minutes of each intravenous perfusion. ]

Measurement of variations of pulse Oxygen saturation (SpO2). Pulse oximetry is a non-invasive measures of oxygen saturation level in %. A normal SpO2 is typically between 95 and 100 percent. A SpO2 < 95 percent is considered low.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Male and female
  • Between 18 and 75 years old
  • Reads and writes French
  • Diagnosis of fibromyalgia syndrome according to Widespread Pain Index (WPI) and Symptom Severity Scale (SSS) score ≥ 13/31
  • Both molecules (Ketamine and Esketamine) were administered at least once during an analgesic infusion session in Pain Clinic
  • Patient with regular medical follow-up by a pain specialist at least 3 times a year

Exclusion Criteria:

  • Allergy or intolerance to Ketamine or Esketamine
  • Current infection, fever
  • Pregnant or breastfeeding woman
  • Serious cardiovascular disorders and severe hypertension
  • Increased pressure of cerebrospinal fluid and severe intracranial disease
  • Acute intermittent porphyria
  • Untreated epilepsy
  • Untreated glaucoma
  • Difficult or impossible intravenous access
  • Chronic Liver Disease Child-Pugh C
Open or close this module Contacts/Locations
Central Contact Person: Brice Constant, MD
Telephone: 0032477504934
Email: briceconstant@hotmail.com
Central Contact Backup: Romain Dehavay, MD
Telephone: 0032476684876
Email: romain.dehavay@gmail.com
Study Officials: Brice Constant, MD
Principal Investigator
Centre Universitaire de Charleroi
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
IPD will be available according to reasonable demands.
Open or close this module References
Citations:
Links:
Available IPD/Information:

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