Clinical Trial

Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study

Study acronym: SUNRISE
Recruiting
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Record status
This record was last updated December 24, 2024 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
Summary
The aim of this observational study is to evaluate the effects of cannabis extract Avextra 10/10 solution on pain, fatigue, sleep, and quality of life among patients affected by fibromyalgia (FM) syndrome. The main question it aims to answer is: Does cannabis extract have a positive effect on pain after 12 weeks in these patients? Participants diagnosed from FM will be evaluated and will fill survey about their pain, fatigue, sleep, anxiety, depression and quality of life at baseline, 4 weeks, 8 weeks and 12 weeks after the initiation of cannabis extract Avextra 10/10 solution.
Trial Details
NCT Number NCT06747039
Lead Sponsor I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Conditions Fibromyalgia (FM)
Enrollment 38 participants
Start Date 2024-12-05
Primary Completion 2025-09 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-12-24