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

NCT07157852 | Recruiting DMC

• 1 other identifier: KY2025-217-03-01
• Study Type: interventional
• Target: 674
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Pregabalin; Mirogabalin; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• 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 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

Study Arms (2)

Pregabalin group

ACTIVE COMPARATOR

Drug: Pregabalin

Mirogabalin group

EXPERIMENTAL

Drug: Mirogabalin

Interventions

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.

Mirogabalin group

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.

Pregabalin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Chongqing Three Gorges Central Hospital: collaborator
• the First People Hospital of Yunnan Province: collaborator
• China-Japan Friendship Hospital: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Peking University Third Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, China

RECRUITING

Related Links

• Mathieson S, Lin C-WC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020;369:m1315. doi: 10.1136/bmj.m1315
• 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.
• 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
• 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
• 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

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

mirogabalin; Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Fang Luo

CONTACT

+8613611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Pain Management, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 5, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 4, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)