- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04938713
Comparison of Ketamine and Esketamine in Patients Suffering From Fibromyalgia Syndrome. (KESK-FIQ)
Comparison of Ketamine and Esketamine in Ambulatory Patients Treated for Fibromyalgia Syndrome in Pain Clinic. A Single-center, Prospective, Randomized, Double-blind, Crossover Study.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brice Constant, MD
- Phone Number: 0032477504934
- Email: briceconstant@hotmail.com
Study Contact Backup
- Name: Romain Dehavay, MD
- Phone Number: 0032476684876
- Email: romain.dehavay@gmail.com
Study Locations
-
-
Hainaut
-
Lodelinsart, Hainaut, Belgium, 6042
- Recruiting
- CHU de Charleroi
-
Contact:
- Romain Dehavay, MD
- Phone Number: 0032476684876
- Email: romain.dehavay@gmail.com
-
Contact:
- Brice JD Constant, MD
- Phone Number: 0032477504934
- Email: briceconstant@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Intravenous Ketalar® 0,30 mg/kg in 1 hour.
Intravenous Vesierra® 0,15mg/kg in 1 hour.
|
Other: 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. |
Intravenous Ketalar® 0,30 mg/kg in 1 hour.
Intravenous Vesierra® 0,15mg/kg in 1 hour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At day 0 before starting each intravenous perfusion.
|
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.
|
At day 7 after each intravenous perfusion.
|
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.
|
At day 14 after each intravenous perfusion.
|
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.
|
At day 21 after each intravenous perfusion.
|
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.
|
At day 28 after each intravenous perfusion.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At the beginning (minute zero) of each intravenous perfusion.
|
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.
|
After 30 minutes of each intravenous perfusion.
|
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.
|
After 60 minutes of each intravenous perfusion.
|
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.
|
After 90 minutes of each intravenous perfusion.
|
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.
|
After 120 minutes of each intravenous perfusion.
|
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.
|
At the beginning (minute zero) of each intravenous perfusion.
|
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.
|
After 30 minutes of each intravenous perfusion.
|
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.
|
After 60 minutes of each intravenous perfusion.
|
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.
|
After 90 minutes of each intravenous perfusion.
|
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.
|
After 120 minutes of each intravenous perfusion.
|
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.
|
At the beginning (minute zero) of each intravenous perfusion.
|
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.
|
After 30 minutes of each intravenous perfusion.
|
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.
|
After 60 minutes of each intravenous perfusion.
|
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.
|
After 90 minutes of each intravenous perfusion.
|
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.
|
After 120 minutes of each intravenous perfusion.
|
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.
|
At the beginning (minute zero) of each intravenous perfusion.
|
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.
|
After 30 minutes of each intravenous perfusion.
|
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.
|
After 60 minutes of each intravenous perfusion.
|
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.
|
After 90 minutes of each intravenous perfusion.
|
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.
|
After 120 minutes of each intravenous perfusion.
|
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.
|
At the beginning (minute zero) of each intravenous perfusion.
|
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.
|
After 30 minutes of each intravenous perfusion.
|
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.
|
After 60 minutes of each intravenous perfusion.
|
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.
|
After 90 minutes of each intravenous perfusion.
|
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.
|
After 120 minutes of each intravenous perfusion.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Brice Constant, MD, Centre Universitaire de Charleroi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Fibromyalgia
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Psychotropic Drugs
- Antidepressive Agents
- Ketamine
- Esketamine
Other Study ID Numbers
- KESK-FIQ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fibromyalgia
-
University of AberdeenCompletedFibromyalgia | Fibromyalgia, Primary | Fibromyalgia, SecondaryUnited Kingdom
-
Eli Lilly and CompanyCompletedFibromyalgia, Primary | Fibromyalgia, SecondaryMexico
-
Rasmia ElgoharyNot yet recruiting
-
Tel-Aviv Sourasky Medical CenterCompletedFibromyalgia (FM)Israel
-
Yousra Hisham Abdel FattahCompletedFibromyalgia, PrimaryEgypt
-
Forest LaboratoriesCypress Bioscience, Inc.TerminatedPrimary FibromyalgiaUnited States
-
Universidade Federal do Rio Grande do NorteCompleted
-
Tonix Pharmaceuticals, Inc.CompletedPrimary FibromyalgiaUnited States
-
Tonix Pharmaceuticals, Inc.CompletedPrimary FibromyalgiaUnited States
-
University of ManitobaCompleted
Clinical Trials on Ketamine 50 MG/ML
-
University Hospital MuensterVifor PharmaTerminatedAnemia | Orthopedic Surgery | High Risk of Blood LossGermany
-
Lawson Health Research InstituteCompletedPostoperative Air LeakCanada
-
Biosynexus IncorporatedCompletedStaphylococcal SepsisUnited States
-
Adapt Produtos Oftalmológicos Ltda.WithdrawnOcular Hypertension | Open Angle GlaucomaBrazil
-
Ullevaal University HospitalUniversity of OsloCompleted
-
PfizerCompleted
-
Bausch Health Americas, Inc.Completed
-
Rare Disease Research, LLCSarepta Therapeutics, Inc.TerminatedDuchenne Muscular DystrophyUnited States
-
Bausch Health Americas, Inc.Withdrawn
-
Laboratorios Leti, S.L.CompletedAllergy | Rhinitis | Rhinoconjunctivitis | Seasonal AsthmaSpain