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| Name | Class |
|---|---|
| Chongqing Three Gorges Central Hospital | OTHER |
| Affiliated Hospital of Yanbian University | UNKNOWN |
| The First Affiliated Hospital of Army Medical University (Southwest Hospital) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin group | Active Comparator |
| |
| Mirogabalin group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirogabalin | Drug | For the mirogabalin group, therapy will begin at 5mg twice daily. If the pain will remain inadequately controlled after one week without significant adverse effects, the dose will be escalated in 5 mg per day increments at weekly intervals, with a maximum allowable dose of 15mg twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients achieving pain relief | 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. | At the 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The average pain intensity | The average pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable. | At the weeks 1, 2, 4, 8, and 12 |
| The worst pain intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo | Contact | +8613611326978 | 13611326978@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Beijing, Beijing 100070 | Recruiting | Beijing | China |
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| Label | URL |
|---|---|
| Mathieson S, Lin C-WC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020;369:m1315. doi: 10.1136/bmj.m1315 | View source |
| Domon Y, Arakawa N, Inoue T, Matsuda F, Takahashi M, Yamamura N, et al. Binding Characteristics and Analgesic Effects of Mirogabalin, a Novel Ligand for the α2δ Subunit of Voltage-Gated Calcium Channels. J Pharmacol Exp Ther. 2018;365(3):573-82. doi: 10. | View source |
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Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| C000598618 | mirogabalin |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| The First Affiliated Hospital of Nanchang University | OTHER |
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|
| Pregabalin | Drug | For the pregabalin group, treatment will be initiated at a dosage of 150 mg daily, administered into 2 or 3 divided doses. After 3 to 7 days, the dose will be titrated to 300 mg per day, with subsequent incremental increases of 150 mg daily permitted at 3-day to 7-day intervals based on therapeutic response and tolerability, up to a maximum dose of 450 mg daily. |
|
The worst pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
| At the weeks 1, 2, 4, 8, and 12 |
| The average weekly consumption of rescue analgesics | Acetaminophen is permitted as rescue medication for intolerable FM-related pain. The maximum allowable dose is 1000 mg per administration and not exceeding 3000 mg per day. All rescue medication use will be recorded prospectively in patient diaries, including date, dose, and frequency of administration. | At the weeks 4, 8, and 12 |
| The Revised FM Impact Questionnaire | The Revised FM Impact Questionnaire is a 21-item self-administered questionnaire, based on symptoms reported within the preceding 7 days. The total score ranges from 0 to 100, with higher values indicating worse health status. | At the weeks 4, 8, and 12 |
| The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales | The BPI-S assesses pain intensity over the past 24 hours, including 4 items. The BPI-I evaluates the degree to which pain interferes with daily activities, comprising 7 items. Each BPI item is rated on a 0 to 10 NRS, with 0 represents no pain or does not interfere, and 10 represents worst pain imaginable or interferes completely. Higher scores indicate greater pain severity or interfere. | 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 | The short-form 36 Health Survey (SF-36) | At the weeks 4, 8, and 12 |
| The Medical Outcomes Study Sleep Scale (MOS) | The MOS uses a 6-point scale to evaluate various dimensions of sleep, consisting of 12 items. A score of 1 indicates persistent presence, with a score of 6 denotes complete absence. | At the weeks 4, 8, and 12 |
| The Beck Depression Inventory-Ⅱ (BD-Ⅱ) | The BD-Ⅱ employs a 4-point scale (ranging from 0 to 3) to evaluate the severity of depressive symptoms, comprising 21 items in total. A score of 0 indicates the absence of symptoms, while a score of 3 reflects severe symptomatology. | At the weeks 4, 8, and 12 |
| The Patient Global Impression of Change (PGIC) Scale | The PGIC is a 7-point patient-reported global rating scale that assesses overall change in health status since the start of treatment. Participants rate their condition as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. | At week 12 |
| Adverse Events | Adverse Events are defined as events that occur the course of treatment, were not present before prior to the intervention, or represent a worsening of pre-existing conditions. These events will be systematically documented and categorized by severity into grades such as mild, moderate, severe, or life-threatening. | Through study completion, an average of 12 weeks |
| Saeki K, Yasuda S-I, Kato M, Kano M, Domon Y, Arakawa N, et al. Analgesic effects of mirogabalin, a novel ligand for α2δ subunit of voltage-gated calcium channels, in experimental animal models of fibromyalgia. Naunyn Schmiedebergs Arch Pharmacol. 2019;3 | View source |
| Murasawa H, Pawlak A, Kobayashi H, Saeki K, Yasuda S-I, Kitano Y. Mirogabalin, a novel ligand for α2δ subunit of voltage-gated calcium channels, improves cognitive impairments in repeated intramuscular acidic saline injection model rats, an experimental | View source |
| Murasawa H, Kobayashi H, Yasuda S-I, Saeki K, Domon Y, Arakawa N, et al. Anxiolytic-like effects of mirogabalin, a novel ligand for α2δ ligand of voltage-gated calcium channels, in rats repeatedly injected with acidic saline intramuscularly, as an experi | View source |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |