Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study
Key facts
- Who runs it
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 38 people, planned
- Started
- 5 Dec 2024
- Planned end
- Dec 2025
- Type of study
- Observational
- Record updated
- 24 December 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
- Able to provide informed consent, according to requirements of local IRB/ethics committee
Who cannot take part
- Patients who have not received stable therapy for pain, sleep disorders, or any psychiatric condition for at least 2 weeks
- Concomitant diagnosis of other pathologies that could interfere with clinical judgment
- Known history of pain not due to FM
- Psychiatric diagnosis according to DSM-V-TR
- Patients who are taking other types of medical cannabis besides Avextra 10/10 solution
- Pregnancy or breastfeeding
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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.
The group in the trial
- Patients with a diagnosis of FM after failure and/or intolerance of first- and second-line treatment
Patients with a diagnosis of FM according to 2016 American College of Rheumatology Criteria, aged 18 years and older, able to fully understand and fill questionnaires and to provide fully informed consent, who failed and/or were intolerant of first- or second-line treatment.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- ObServational StUdy of CaNnabis ExtRact in FIbromyalgia SyndromE
- Record updated
- 24 December 2024