ObServational StUdy of CaNnabis ExtRact in FIbromyalgia SyndromE

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Ospedale Galeazzi-Sant'Ambrogio
RECRUITING
Milan
Contact Information
Primary
Greta Pellegrino, Medical Doctor
greta.pellegrino@grupposandonato.it
0283500010
Backup
Piercarlo Sarzi Puttini, Medical Doctor
piercarlo.sarziputtini@grupposandonato.it
0283500010
Time Frame
Start Date: 2024-12-05
Estimated Completion Date: 2025-12
Participants
Target number of participants: 38
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

This content was sourced from clinicaltrials.gov