Evaluating cannabis extract for fibromyalgia symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the effects of the cannabis extract Avextra 10/10 solution on pain, fatigue, sleep, and quality of life in patients diagnosed with fibromyalgia syndrome. Participants will complete surveys regarding their symptoms at baseline, and then again at 4, 8, and 12 weeks after starting the treatment. The primary focus is to determine if the cannabis extract can significantly reduce pain after 12 weeks of use. Secondary objectives include evaluating its impact on fatigue, sleep, anxiety, and depression over the same period.

Why it matters

Who can join: the full rules

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

Where it's running

• IRCCS Ospedale Galeazzi-Sant'Ambrogio
  Milan, Milano, Italy Recruiting

Study contacts

• Principal investigator: Piercarlo Sarzi Puttini, Medical Doctor — IRCCS Ospedale Galeazzi Sant'Ambrogio
• Study coordinator: Greta Pellegrino, Medical Doctor
• Email: greta.pellegrino@grupposandonato.it
• Phone: 0283500010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.