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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-05

Study Completion Date

2027-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Fibromyalgia Pregabalin Mirogabalin Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pregabalin group

Group Type ACTIVE_COMPARATOR

Pregabalin

Intervention Type 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 600 mg daily.

Mirogabalin group

Group Type EXPERIMENTAL

Mirogabalin

Intervention Type 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.

Interventions

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Mirogabalin

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.

Intervention Type DRUG

Pregabalin

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 600 mg daily.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No