Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study
ConditionFibromyalgia (FM)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
About this trial
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.
Eligibility criteria
Qualifiers
Patients with a diagnosis of FM according to 2016 American College of Rheumatology Criteria.
Patients with FM prescribed cannabis extract Avextra 10/10 solution after failure and/or intolerance of first- or second-line treatment.
Aged 18 years and older.
Able to fully understand and fill questionnaires.
Disqualifiers
Known history of pain not due to FM.
Patients who have not received stable therapy for pain, sleep disorders, or any psychiatric condition for at least 2 weeks.
Patients who are taking other types of medical cannabis besides Avextra 10/10 solution.
Concomitant diagnosis of other pathologies that could interfere with clinical judgment.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
38 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov