The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia

Beijing Tiantan Hospital106 enrolled

Overview

Fibromyalgia is a chronic pain syndrome where current medications have limited efficacy and a slow onset of action. Esketamine shows potential as a rapid-acting analgesic, but previous low-dose studies failed to demonstrate long-term benefits. The efficacy of higher-dose ESK as an adjunctive therapy when standard treatments are insufficient remains unclear.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Fibromyalgia Pregabalin Esketamine

Interventions

Pregabalin and venlafaxine concomitant therapyDRUG

The control group will only receive an increased dosage of pregabalin and venlafaxine regimen. Each participant will be instructed with the same dose escalation regimen, until they reach the maximal tolerated dose (MTD) or the ceiling dose or the maximum daily recommended dose. The maximum recommended daily dose of pregabalin was 450 mg and venlafaxine was 225 mg.

Esketamine plus pregabalin and venlafaxine concomitant therapyDRUG

The treatment group, in addition to the increased pregabalin and venlafaxine medication dosage regimen, will also receive a single intravenous infusion of esketamine on the day of enrollment. Plasma concentrations of esketamine and its metabolites will be measured at the end of infusion to enable a limited characterization of systemic exposure and to support exploratory exposure-response analyses. Each participant will be instructed with the same dose escalation regimen, until they reach the maximal tolerated dose (MTD) or the ceiling dose or the maximum daily recommended dose. The maximum recommended daily dose of pregabalin was 450 mg and venlafaxine was 225 mg.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients between ages over 18 years with proper cognitive function and language skills for the study; * Patients diagnosed with FM as defined by the ACR FM diagnostic criteria; * Patients who have experienced insufficient symptom relief with non-pharmacological treatments and have not previously received recommended pharmacological treatment for FM; * A score of ≥ 4 on the average pain intensity over 7 days on the numeric rating scale (NRS) at baseline. Exclusion criteria: * Patient refusal; * Inability to sign informed consent; * Had other secondary FM, this is, hypothyroidism, nutritional deficiency, diabetes mellitus, connective tissue disorder; * Had psychiatric disorder, this is, schizophrenia and other psychotic disorder, bipolar disorder, or personality disorder; * Obstructive sleep apnea syndrome or a STOP-Bang score ≥ 3; * History of treatment with pregabalin and/or venlafaxine for any disease; * History of treatment with intravenous ketamine or ESK for chronic pain; * Presence of other painful ailments such as inflammatory rheumatic disease; * Uncontrolled diabetes, refractory hypertension, malignancies, narrow-angle glaucoma, hyperthyroidism, severe cardiovascular disease or any other contraindications to esketamine; * History of prescription drug abuse, alcoholism or illicit drug use; * Pregnant or lactating women; * Allergic to any of the study drugs.

Locations (1)

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

The median pain relief time

The median pain relief time, defined as the time of 50% decrease in NRS score from baseline. Pain intensity will be measured using the NRS, where 0 indicates no pain, and 10 represents the worst imaginable pain.

Time frame: At 15 minutes, 1 hour, and 3 hours following termination of treatment, days 1, 3, 5, weeks 1, 2, 4, 8, and 12 for a total of 12 weeks.

Secondary Outcomes

Average pain intensity

The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.

Time frame: At the weeks 1, 2, 4, 8, and 12

Worst pain intensity

The worst pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.

Time frame: at weeks 1, 2, 4, 8, and 12

Proportion of patients achieving pain reduction at 50% and 30%;

The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.

Time frame: at weeks 1, 2, 4, 8, and 12

The maximal tolerated doses of pregabalin and venlafaxine

Time frame: at weeks 1, 2, 4, 8, and 12

The Revised FM Impact Questionnaire (FIQR)

The FIQR is used to assessed health status and functional disablity. FIQR is a 21-item self-administered questionnaire, based on symptoms reported within the preceding 7 days. FIQR total score ranges from 0 to 100, with higher values indicating worse health status.

Central Contacts

Fang Luo

CONTACT

+8613611326978 15383510462@163.com

Data from ClinicalTrials.gov

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