Actively Recruiting
Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study
Led by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Updated on 2024-12-24
38
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with fibromyalgia according to 2016 American College of Rheumatology Criteria
- Patients prescribed cannabis extract Avextra 10/10 solution after failure or intolerance of first- or second-line treatments
- Age 18 years or older
- Able to understand and complete questionnaires
- Able to provide informed consent per local ethics requirements
You will not qualify if you...
- Known history of pain not caused by fibromyalgia
- Not receiving stable therapy for pain, sleep disorders, or psychiatric conditions for at least 2 weeks
- Using other types of medical cannabis besides Avextra 10/10 solution
- Having other medical conditions that could affect clinical evaluation
- Psychiatric diagnosis according to DSM-V-TR
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Milano, Italy, 20157
Actively Recruiting
Research Team
G
Greta Pellegrino, Medical Doctor
CONTACT
P
Piercarlo Sarzi Puttini, Medical Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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