ESKETamine for FIBromyalgia Treatment

NCT04436250 | Terminated

• 1 other identifier: ESKEFIB
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Number of patients showing 50 % reduction in the BPI (Brief Pain Inventory) pain index

  12 weeks

Study Arms (3)

Placebo

ACTIVE COMPARATOR

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

Drug: Active comparator

S-Ketamine Low dose

EXPERIMENTAL

S-Ketamine at a dose of 0.2 mg/kg

Drug: Active comparator; Drug: S-Ketamine Low dose

S-ketamine High dose

EXPERIMENTAL

S-ketamine at a dose of 0.4 mg/kg

Drug: Active comparator; Drug: S-Ketamine High dose

Interventions

Active comparator DRUG

The active comparator is composed of clonidine 1 microg/kg combined with magnesium sulfate 40 mg/kg diluted in 45 ml of sodium chloride

Placebo; S-Ketamine Low dose; S-ketamine High dose

S-Ketamine Low dose DRUG

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.

S-Ketamine Low dose

S-Ketamine High dose DRUG

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.

S-ketamine High dose

Eligibility Criteria

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

You may qualify if:

• 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

Sponsors & Collaborators

• Grand Hôpital de Charleroi: lead

Study Sites (1)

Grand Hôpital de Charleroi

Gilly, Hainaut, 6060, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34838114 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Jean-Paul Lechat, MD

  Grand Hôpital de Charleroi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 18, 2020
• Study Start: October 10, 2020
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

BE (1)