The Efficacy and Safety of Crisugabalin (HSK16149) in Fibromyalgia Patients: Protocol for a Prospective Randomized Open Blinded-Endpoint (PROBE) Study - PubMed
3 days ago
- #fibromyalgia
- #clinical-trial
- #pain-management
- Study evaluates efficacy and safety of Crisugabalin (HSK16149) compared to pregabalin in fibromyalgia patients.
- Multicenter, randomized, open-label, blinded-endpoint (PROBE) study in 10 Chinese hospitals with 1116 participants.
- Primary outcome: proportion of patients achieving ≥50% reduction in average pain intensity at week 12.
- Secondary outcomes include pain measures, quality of life, sleep, depression scales, and adverse events.
- Study approved by Beijing Tiantan Hospital ethics committee, adhering to Declaration of Helsinki.
- Results to be disseminated via peer-reviewed publications and conferences.