Comparing the Efficacy and Safety of Pregabalin Monotherapy Versus Other Neuromodulatory Drugs (Mirogabalin) in the Treatment of Fibromyalgia: A Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 674
- 试验地点
- 1
- 主要终点
- The proportion of patients achieving pain relief
研究概览
简要总结
Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Mirogabalin, a new highly selective α2δ ligand, has shown potential in animal models or preliminary clinical trials, but there is insufficient evidence for its application in FM. This study aims to explore the effectiveness and safety of pregabalin or mirogabalin in treating FM, with the aim of providing a better treatment option for FM patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;[1]
- •Aged over 18 years old;
- •Suffering from moderate to severe FM, refractory to non-pharmacological interventions and without prior exposure to recommend pharmacological treatments for FM;
- •Baseline numeric rating scale (NRS) score of 4 or higher;
- •Aspartate aminotransferase and alanine aminotransferase levels below twice the upper limit of normal range;
- •Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m²;
- •Willingness to provide informed consent and adequate cognitive and language capabilities to meet all study requirements;
排除标准
- •Previous allergic reactions to pregabalin, mirogabalin, or any of their excipients;
- •Prior diagnosis of epilepsy or depression requiring antidepressant therapy;
- •Women who are pregnant or breastfeeding;
- •Has severe systemic illnesses, such as poorly controlled hypertension, poorly controlled diabetes mellitus, or significant cardiac impairment;
- •Suffering from acute or chronic pain disorders other than FM.
研究组 & 干预措施
Pregabalin group
干预措施: Pregabalin (Drug)
Mirogabalin group
干预措施: Mirogabalin (Drug)
结局指标
主要结局
The proportion of patients achieving pain relief
时间窗: At the 12-weeks
The proportion of patients achieving pain relief defined as the proportion of patients whose baseline average pain intensity is reduced by at least 50%. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
次要结局
- The average pain intensity(At the weeks 1, 2, 4, 8, and 12)
- The worst pain intensity(At the weeks 1, 2, 4, 8, and 12)
- The Beck Depression Inventory-Ⅱ (BD-Ⅱ)(At the weeks 4, 8, and 12)
- The average weekly consumption of rescue analgesics(At the weeks 4, 8, and 12)
- The Revised FM Impact Questionnaire(At the weeks 4, 8, and 12)
- The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales(At the weeks 4, 8, and 12)
- The SF-36 is utilized to assess health-related quality of life, encompassing preference across different health states. It evaluates 8 distinct domains, with each domain scored on a scale ranging from 0 to 100, wher(At the weeks 4, 8, and 12)
- The Medical Outcomes Study Sleep Scale (MOS)(At the weeks 4, 8, and 12)
- The Patient Global Impression of Change (PGIC) Scale(At week 12)
- Adverse Events(Through study completion, an average of 12 weeks)
研究者
Fang Luo
Director, Department of Pain Management, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital