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

Launched by BEIJING TIANTAN HOSPITAL ·

Keywords

ClinConnect Summary

This trial is comparing two medicines often used for nerve-related pain to see which works better for adults with fibromyalgia: mirogabalin (experimental) vs. pregabalin (an established treatment). About 362 adults with fibromyalgia will be enrolled across centers in China, starting around September 2025, with results expected by 2027. The study is randomized but not blinded, meaning participants know which drug they’re taking, and it will compare the two drugs directly over about two months.

To be eligible, you would need to be 18 or older, have a fibromyalgia diagnosis, and have moderate to severe pain (a baseline pain score of 4 or higher on a 0–10 scale). You should not have used recommended pharmacological FM treatments before, and you must have normal liver tests and adequate kidney function. Exclusions include allergies to these drugs, epilepsy or significant depression requiring treatment, pregnancy, other serious illnesses, or other chronic pain conditions. Participants will be assigned to one drug or the other and followed to see how many achieve meaningful pain relief by 4 weeks, along with changes in daily pain, sleep, mood, and quality of life. Safety will be monitored for adverse events throughout the study. Dosing starts with mirogabalin at 5 mg twice daily (can increase up to 15 mg twice daily) and pregabalin starting at 150 mg daily (up to 600 mg daily as tolerated).

Gender

ALL

Eligibility criteria