The Efficacy and Safety of Crisugabalin (HSK16149) in Fibromyalgia Patients: Protocol for a Prospective Randomized Open Blinded-Endpoint (PROBE) Study.
Minying Liu, Renshu Li, Huacheng Zhou...
https://pubmed.ncbi.nlm.nih.gov/41800444/Actively Recruiting
Led by Beijing Tiantan Hospital · Updated on 2026-02-11
1116
Participants Needed
1
Research Sites
8 weeks
Total Duration
Fibromyalgia FM is a long-lasting pain condition marked by widespread pain, tiredness, and emotional difficulties. It is linked to changes in the nervous system and chemical imbalances. Current treatments like pregabalin only help some patients and often cause side effects. Researchers are studying pregabalin and a newer drug called crisugabalin to see which might provide better relief and safety for people with FM. Participants will be randomly assigned to one of two groups one group will receive pregabalin starting at 150 mg daily with possible increases up to 450 mg daily based on how well it works and is tolerated. The other group will receive crisugabalin starting at 20 mg twice daily, with a maximum dose of 40 mg twice daily. The study will last about 12 weeks to assess these treatments. During the study, participants will regularly report their pain levels and complete questionnaires about their health, sleep, mood, and daily function. Researchers will monitor medication doses, use of additional pain relief, and any side effects throughout the 12 weeks. The main goal is to see how many patients experience pain relief at 12 weeks, with other measures taken at various points to understand the treatments effects and safety.
CONDITIONS
The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia
F
Fang Luo, M.D.
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Beijing Tiantan Hospital
Lead Sponsor
China-Japan Friendship Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either pregabalin or crisugabalin to treat fibromyalgia. Dosages are adjusted based on response and tolerability with careful monitoring.
Visits at weeks 1, 2, 4, 8, and 12
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Minying Liu, Renshu Li, Huacheng Zhou...
https://pubmed.ncbi.nlm.nih.gov/41800444/Beijing Tiantan Hospital
Lead Sponsor
China-Japan Friendship Hospital
Collaborating Sponsor