Clinical Trial

Efficacy and Safety of Pregabalin/Tizanidine vs. Pregabalin in Patients With Fibromyalgia

Not Yet Recruiting
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Record status
This record was last updated February 4, 2026 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
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 neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common.Tizanidine is an imidazoline derivative and a centrally acting alpha-2 receptor agonist with skeletal muscle relaxant, sedative and anxiolytic properties.we carried out an open-label clinical trial in order to evaluate the efficacy and safety of combined treatment with tizanidine and pregabalin for pain in FM.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-26.
Trial Details
NCT Number NCT07382921
Lead Sponsor Beijing Tiantan Hospital
Collaborators: People's Hospital of Xinjiang Uygur Autonomous Region, Sichuan Provincial People's Hospital
Conditions Fibromyalgia, Pregabalin, Pain
Enrollment 164 participants
Start Date 2026-01-30
Primary Completion 2026-05 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-02-04