FibromyalgiaKESK-FIQNCT04938713
Comparison of Ketamine and Esketamine in Patients Suffering From Fibromyalgia Syndrome.
A study testing Ketamine 50 MG/ML and Esketamine 25 MG/ML in people with Fibromyalgia, run by Centre Hospitalier Universitaire de Charleroi at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Ketamine 50 MG/ML and Esketamine 25 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Untreated epilepsy
- Untreated glaucoma
- Difficult or impossible intravenous access
- Chronic Liver Disease Child-Pugh C
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU de Charleroi
Lodelinsart, Hainaut, 6042
Brice JD Constant, MD, 0032477504934, briceconstant@hotmail.com
Romain Dehavay, MD, 0032476684876, romain.dehavay@gmail.com
About this study
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.
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Ketamine 50 MG/ML, Esketamine 25 MG/ML
- Keywords
- Fibromyalgia, Ketamine, Esketamine, Fibromyalgia Impact Questionnaire, Side effects, Chronic pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine 50 MG/MLDrug
Intravenous Ketalar® 0,30 mg/kg in 1 hour.
Esketamine 25 MG/MLDrug
Intravenous Vesierra® 0,15mg/kg in 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| AB group | Active comparator | 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. Receives: Drug: Ketamine 50 MG/ML; Drug: Esketamine 25 MG/ML |
| BA group | Other | 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. Receives: Drug: Ketamine 50 MG/ML; Drug: Esketamine 25 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score variations of Fibromyalgia Impact Questionnaire
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.
Measured: At day 0 before starting each intravenous perfusion.
Score variations of Fibromyalgia Impact Questionnaire
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.
Measured: At day 7 after each intravenous perfusion.
Score variations of Fibromyalgia Impact Questionnaire
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.
Measured: At day 14 after each intravenous perfusion.
Score variations of Fibromyalgia Impact Questionnaire
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.
Measured: At day 21 after each intravenous perfusion.
Score variations of Fibromyalgia Impact Questionnaire
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.
Measured: At day 28 after each intravenous perfusion.
Secondary outcomes (25)
Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
Measured: At the beginning (minute zero) of each intravenous perfusion.
Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
Measured: After 30 minutes of each intravenous perfusion.
Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
Measured: After 60 minutes of each intravenous perfusion.
Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
Measured: After 90 minutes of each intravenous perfusion.
Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
Measurement of heart rate in Pain clinic during intravenous perfusion. Measurement in beat per minute.
Measured: After 120 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for pain.
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.
Measured: At the beginning (minute zero) of each intravenous perfusion.
Variations of Visual Analogue Scale for pain.
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.
Measured: After 30 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for pain.
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.
Measured: After 60 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for pain.
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.
Measured: After 90 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for pain.
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.
Measured: After 120 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for nausea.
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.
Measured: At the beginning (minute zero) of each intravenous perfusion.
Variations of Visual Analogue Scale for nausea.
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.
Measured: After 30 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for nausea.
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.
Measured: After 60 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for nausea.
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.
Measured: After 90 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for nausea.
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.
Measured: After 120 minutes of each intravenous perfusion.
Variations of non-invasive blood pressure.
Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
Measured: At the beginning (minute zero) of each intravenous perfusion.
Variations of non-invasive blood pressure.
Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
Measured: After 30 minutes of each intravenous perfusion.
Variations of non-invasive blood pressure.
Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
Measured: After 60 minutes of each intravenous perfusion.
Variations of non-invasive blood pressure.
Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
Measured: After 90 minutes of each intravenous perfusion.
Variations of non-invasive blood pressure.
Measurement of variations of systolic and diastolic non-invasive blood pressure with upper arm cuff. Measurement in mmHg.
Measured: After 120 minutes of each intravenous perfusion.
Variations of pulse Oxygen saturation.
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.
Measured: At the beginning (minute zero) of each intravenous perfusion.
Variations of pulse Oxygen saturation.
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.
Measured: After 30 minutes of each intravenous perfusion.
Variations of pulse Oxygen saturation.
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.
Measured: After 60 minutes of each intravenous perfusion.
Variations of pulse Oxygen saturation.
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.
Measured: After 90 minutes of each intravenous perfusion.
Variations of pulse Oxygen saturation.
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.
Measured: After 120 minutes of each intravenous perfusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Jul 2021
- Primary completion1 May 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Charleroi
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Responsible party
- Principal investigator, Brice Constant, MD, Centre Hospitalier Universitaire de Charleroi
- Investigators
- Brice Constant, MD, Principal investigator, Centre Universitaire de Charleroi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938713
- Sponsor's protocol ID
- KESK-FIQ
- Acronym
- KESK-FIQ
- Status last verified
- Aug 2021
- First submitted
- 17 Jun 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available according to reasonable demands.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04938713
- Acronym / sponsor ID
- KESK-FIQ / KESK-FIQ
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Ketamine, Esketamine, Fibromyalgia Impact Questionnaire, Side effects, Chronic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de CharleroiUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AB group | Active comparator | Drug: Ketamine 50 MG/ML, Drug: Esketamine 25 MG/MLIf 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. |
| BA group | Other | Drug: Ketamine 50 MG/ML, Drug: Esketamine 25 MG/MLIf 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine 50 MG/MLIntravenous Ketalar® 0,30 mg/kg in 1 hour. | Drug | AB group, BA group |
| Esketamine 25 MG/MLIntravenous Vesierra® 0,15mg/kg in 1 hour. | Drug | AB group, BA group |
Primary outcome
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.
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.
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.
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.
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.
25 secondary outcomes
Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
Time frame: 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.
Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
Time frame: 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.
Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine
Time frame: 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.
Variations of Visual Analogue Scale for pain.
Time frame: After 30 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for pain.
Time frame: After 60 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for pain.
Time frame: After 90 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for pain.
Time frame: 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.
Variations of Visual Analogue Scale for nausea.
Time frame: After 30 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for nausea.
Time frame: After 60 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for nausea.
Time frame: After 90 minutes of each intravenous perfusion.
Variations of Visual Analogue Scale for nausea.
Time frame: After 120 minutes of each intravenous perfusion.
Variations of non-invasive blood pressure.
Time frame: At the beginning (minute zero) of each intravenous perfusion.
Variations of non-invasive blood pressure.
Time frame: After 30 minutes of each intravenous perfusion.
Variations of non-invasive blood pressure.
Time frame: After 60 minutes of each intravenous perfusion.
Variations of non-invasive blood pressure.
Time frame: After 90 minutes of each intravenous perfusion.
Variations of non-invasive blood pressure.
Time frame: After 120 minutes of each intravenous perfusion.
Variations of pulse Oxygen saturation.
Time frame: At the beginning (minute zero) of each intravenous perfusion.
Variations of pulse Oxygen saturation.
Time frame: After 30 minutes of each intravenous perfusion.
Variations of pulse Oxygen saturation.
Time frame: After 60 minutes of each intravenous perfusion.
Variations of pulse Oxygen saturation.
Time frame: After 90 minutes of each intravenous perfusion.
Variations of pulse Oxygen saturation.
Time frame: After 120 minutes of each intravenous perfusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: No. IPD will be available according to reasonable demands.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brice Constant, MD principal investigator
Centre Universitaire de Charleroi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine 50 MG/ML and Esketamine 25 MG/ML in people with Fibromyalgia, run by Centre Hospitalier Universitaire de Charleroi at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brice Constant, MD (0032477504934, briceconstant@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score variations of Fibromyalgia Impact Questionnaire (time frame: At day 0 before starting each intravenous perfusion.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.