NCT06747039 Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study
| NCT ID | NCT06747039 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio |
| Condition | Fibromyalgia (FM) |
| Study Type | OBSERVATIONAL |
| Enrollment | 38 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 38 participants in total. It began in 2024-12-05 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Psychiatric diagnosis according to DSM-V-TR * Pregnancy or breastfeeding
Contact & Investigator
Piercarlo Sarzi Puttini, Medical Doctor
PRINCIPAL INVESTIGATOR
IRCCS Ospedale Galeazzi Sant'Ambrogio
Frequently Asked Questions
Who can join the NCT06747039 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fibromyalgia (FM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06747039 currently recruiting?
Yes, NCT06747039 is actively recruiting participants. Contact the research team at greta.pellegrino@grupposandonato.it for enrollment information.
Where is the NCT06747039 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06747039 clinical trial?
NCT06747039 is sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. The principal investigator is Piercarlo Sarzi Puttini, Medical Doctor at IRCCS Ospedale Galeazzi Sant'Ambrogio. The trial plans to enroll 38 participants.
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