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NCT Number: NCT07157852

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

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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Key information

Conditions

Fibromyalgia Mirogabalin Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Pregabalin Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

Location status: Recruiting

Location contact

Fang Luo, M.D.

CONTACT

[email protected]

+86 13611326978

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The proportion of patients achieving pain relief

    Time frame: 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.

Secondary outcomes

  1. The average pain intensity

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

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

  2. The worst pain intensity

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

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

  3. The average weekly consumption of rescue analgesics

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

    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.

  4. The Revised FM Impact Questionnaire

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

    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.

  5. The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales

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

    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.

  6. 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

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

    The short-form 36 Health Survey (SF-36)

  7. The Medical Outcomes Study Sleep Scale (MOS)

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

    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.

  8. The Beck Depression Inventory-Ⅱ (BD-Ⅱ)

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

    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.

  9. The Patient Global Impression of Change (PGIC) Scale

    Time frame: At week 12

    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.

  10. Adverse Events

    Time frame: Through study completion, an average of 12 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo

CONTACT

[email protected]

+8613611326978

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Affiliated Hospital of Yanbian University
  • Chongqing Three Gorges Central Hospital
  • The First Affiliated Hospital of Army Medical University (Southwest Hospital)
  • The First Affiliated Hospital of Nanchang University

Registry information

Official study title

Comparing the Efficacy and Safety of Pregabalin Monotherapy Versus Other Neuromodulatory Drugs (Mirogabalin) in the Treatment of Fibromyalgia: A Multicenter Clinical Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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