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

Официальное название

Comparing the Efficacy and Safety of Conventional Therapy With Conventional Therapy Combined Esketamine in the Treatment of Fibromyalgia: A Multicenter Clinical Study

Обзор

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.

Вмешательства

• Препарат Pregabalin and venlafaxine concomitant therapy
  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.
• Препарат Esketamine plus pregabalin and venlafaxine concomitant therapy
  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 max

Первичные конечные точки

• Change from baseline in the mean pain intensity [Срок оценки: At the week 1.]

Вторичные конечные точки (12)

• Average pain intensity [Срок оценки: At the weeks 1, 2, 4, 8, and 12]
• Worst pain intensity [Срок оценки: at weeks 1, 2, 4, 8, and 12]
• Proportion of patients achieving pain reduction at 50% and 30%; [Срок оценки: at weeks 1, 2, 4, 8, and 12]
• The median pain relief time [Срок оценки: Through study completion, an average of 12 weeks]
• The maximal tolerated doses of pregabalin and venlafaxine [Срок оценки: at weeks 1, 2, 4, 8, and 12]
• The Revised FM Impact Questionnaire (FIQR) [Срок оценки: At the weeks 4, 8, and 12]
• Hospital Anxiety and Depression scale (HADS) [Срок оценки: At the weeks 4, 8, and 12]
• The short-form 36 Health Survey (SF-36) [Срок оценки: At the weeks 4, 8, and 12]
• Multidimensional Fatigue Inventory (MFI) [Срок оценки: At the weeks 4, 8, and 12]
• Medical Outcomes Study Sleep Scale (MOS) [Срок оценки: At the weeks 4, 8, and 12]
• Plasma concentrations of esketamine and its metabolites at the end of infusion [Срок оценки: At the end of esketamine infusion, that is at day 0]
• Adverse events [Срок оценки: Through study completion, an average of 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital, Beijing, Beijing 100070 — Пекин

Публикации

• Shrestha N, Liu M, Niu S, Cheng H, Sun Y, Mei S, Luo F. Efficacy and Safety of Adjunctive Therapy Using Single High-Dose S-Ketamine Infusion for Fibromyalgia: A Multicenter, Prospective, Randomized, Controlled, Open-Label, Blinded-Endpoint Study Protocol. J Pain Res. 2026 May 16;19:598907. doi: 10.2147/JPR.S598907. eCollection 2026. PMID 42170615

Идентификаторы

NCT: NCT07230171 · KY2025-217-03-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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