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

NARecruitingINTERVENTIONAL
Enrollment

362

Participants

Timeline

Start Date

September 5, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

August 31, 2027

Conditions
FibromyalgiaPregabalinMirogabalinPain
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 600 mg daily.

Trial Locations (1)

Unknown

RECRUITING

Beijing Tiantan Hospital, Beijing, Beijing 100070, Beijing

All Listed Sponsors
collaborator

Second Affiliated Hospital of Nanchang University

OTHER

collaborator

Chongqing Three Gorges Central Hospital

OTHER

collaborator

the First People Hospital of Yunnan Province

UNKNOWN

collaborator

China-Japan Friendship Hospital

OTHER

collaborator

The First Affiliated Hospital of Nanchang University

OTHER

collaborator

Peking University Third Hospital

OTHER

lead

Beijing Tiantan Hospital

OTHER

NCT07157852 - The Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia | Biotech Hunter | Biotech Hunter