Status:
RECRUITING
The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
China-Japan Friendship Hospital
The First Affiliated Hospital of Nanchang University
Conditions:
Fibromyalgia
Pregabalin
Eligibility:
All Genders
18+ years
Phase:
NA
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 neurotra...
Eligibility Criteria
Inclusion
- Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
- 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
- Previous allergic reactions to pregabalin, crisugabalin, 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.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
1116 Patients enrolled
Trial Details
Trial ID
NCT07196657
Start Date
September 30 2025
End Date
August 31 2027
Last Update
December 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Tiantan Hospital, Beijing, Beijing 100070
Beijing, China