Comparison of Ketamine and Esketamine in Patients Suffering From Fibromyalgia Syndrome.

NCT04938713 | Unknown

• 1 other identifier: KESK-FIQ
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Ketamine; Esketamine; Fibromyalgia Impact Questionnaire; Side effects; Chronic pain

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  At day 28 after each intravenous perfusion.

Secondary Outcomes (25)

• Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine

  At the beginning (minute zero) of each intravenous perfusion.

• Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine

  After 30 minutes of each intravenous perfusion.

• Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine

  After 60 minutes of each intravenous perfusion.

• Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine

  After 90 minutes of each intravenous perfusion.

• Heart rate disturbances after intravenous perfusion of Ketamine or Esketamine

  After 120 minutes of each intravenous perfusion.

Study Arms (2)

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.

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.

Drug: Ketamine 50 MG/ML; Drug: Esketamine 25 MG/ML

Interventions

Ketamine 50 MG/ML DRUG

Intravenous Ketalar® 0,30 mg/kg in 1 hour.

AB group; BA group

Esketamine 25 MG/ML DRUG

Intravenous Vesierra® 0,15mg/kg in 1 hour.

AB group; BA group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Charleroi: lead
• Centre Hospitalier Universitaire de Liege: collaborator

Study Sites (1)

CHU de Charleroi

Lodelinsart, Hainaut, 6042, Belgium

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Ketamine; Esketamine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Brice Constant, MD

  Centre Universitaire de Charleroi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brice Constant, MD

CONTACT

0032477504934; briceconstant@hotmail.com

Romain Dehavay, MD

CONTACT

0032476684876; romain.dehavay@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 24, 2021
• Study Start: July 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: September 30, 2022
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)