The Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia

Not Applicable

Not yet recruiting

• Conditions: Fibromyalgia; Pregabalin; Mirogabalin; Pain
• Interventions: Drug: Pregabalin; Drug: Mirogabalin

• Registration Number: NCT07157852
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-27
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Study Start: 2025-09-15
• Primary Completion: 2027-06-30
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 362

Inclusion Criteria

• 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;

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin group	Pregabalin	-
Mirogabalin group	Mirogabalin	-

Primary Outcome Measures

Name	Time	Method
The proportion of patients achieving pain relief	At the 4-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.

Secondary Outcome Measures

Name	Time	Method
The average pain intensity	At the weeks 1, 2, 4, and 8	The average pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
The worst pain intensity	At the weeks 1, 2, 4, and 8	The worst pain intensity. The pain intensity will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales	At the weeks 1, 2, 4, and 8	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.
The Revised FM Impact Questionnaire	At the weeks 1, 2, 4, and 8	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.
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 1, 2, 4, and 8	The short-form 36 Health Survey (SF-36)
The Medical Outcomes Study Sleep Scale (MOS)	At the weeks 1, 2, 4, and 8	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.
The Beck Depression Inventory-Ⅱ (BD-Ⅱ)	At the weeks 1, 2, 4, and 8	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.
Adverse Events	Through study completion, an average of 8 weeks	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.

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Beijing, Beijing 100070; 🇨🇳 Beijing, China