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

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

Interventions

DRUG

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.

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 450 mg daily.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• Chongqing Three Gorges Central Hospital

  collaborator OTHER

• the First People Hospital of Yunnan Province

  collaborator UNKNOWN

• China-Japan Friendship Hospital

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• Beijing Tiantan Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-05

Primary Completion

2027-06-30

Completion

2027-08-31

Countries

• China

Study Locations