Fibromyalgia (FM)SUNRISENCT06747039
Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study
An observational study of Fibromyalgia (FM), run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia (FM)
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 5 Dec 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients afferent to IRCCS Ospedale Galeazzi Sant- Ambrogio in Milan (Italy) with FIbromyalgia Syndrome who will start therapy with cannabis extract Avextra 10/10.
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Piercarlo Sarzi Puttini, Medical Doctor contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Milano, 20157
About this study
Official title: ObServational StUdy of CaNnabis ExtRact in FIbromyalgia SyndromE
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.
Read the detailed description
Fibromyalgia (FM) is a chronic condition characterized by widespread pain, mechanical hyperalgesia, fatigue, sleep disturbances, psychological and cognitive impairments, mood changes, headaches, migraines, and gastrointestinal symptoms. Despite its recognition as a medical condition with diagnostic criteria and severity scales, its exact causes and effective treatment remain unclear. FM significantly impacts patients' quality of life and poses a societal burden due to high direct and indirect costs.
Cannabis-based treatments have gained attention for FM symptom management. In Italy, therapeutic cannabis has been legal since 2013 and may be prescribed when conventional treatments fail or cause intolerable side effects. Its primary components, tetrahydrocannabinol (THC) and cannabidiol (CBD), interact with cannabinoid receptors to potentially provide pain relief, anti-inflammatory effects, and mood stabilization.
The study aims to evaluate the efficacy of the standardized cannabis extract Avextra 10/10 (10 mg/mL THC and 10 mg/mL CBD) for FM treatment.
Objectives Primary objective: -Assess the extract's impact on pain after 12 weeks.
Secondary objective:
- Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on fatigue, sleep, anxiety and depression after 4, 8 and 12 weeks among patients affected by FM
- Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 4 and 8 weeks among patients affected by FM.
- Evaluate the effect of cannabis extract Avextra 10/10 solution on the quality of life at 4, 8 and 12 weeks among patients affected by FM.
- Describe any adverse events or the principal reasons of drug discontinuation.
Design and Methods This is a monocentric observational prospective study in which patients with FM who undertake cannabis therapy with cannabis extract Avextra 10/10 solution will consecutively be recruited.
Population: The inclusion criteria are:
- Patients with a diagnosis of FM according to 2016 American College of Rheumatology Criteria [2].
- 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.
The exclusion criteria are:
- 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
All patients with FM will undergo a standard clinical assessment, at baseline and at the follow-up visits, as part of the routine clinical practice. After the baseline visit, corresponding to the appointment where medical cannabis is prescribed within two weeks before the undertake of cannabis extract, follow-up visits will be scheduled according to routine clinical practice as follow:
- 15 days after the undertake of cannabis extract (T15)
- 30 days after the undertake of cannabis extract (T30)
- 60 days after the undertake of cannabis extract (T60)
- 90 days after the undertake of cannabis extract (T90)
- 6 months after the undertake of cannabis extract. All patients with FM will undergo a standard clinical assessment, at baseline and at the follow-up visits, as part of the routine clinical practice.
Data collected from participants during clinical evaluations at baseline visit will include:
- Demographic data: age, gender, BMI, residence
- Educational qualification
- Occupational status
- Age at menopause (if applicable)
- Current medication
- Comorbidities
- Symptom duration
- Age at FM diagnosis
- Number of sure tender point
- Smoke status
- Physical activity
Data collected from participants during clinical evaluations at follow-up visit will include:
- Number of sure tender point
- Smoke status
- Physical activity
- Efficacy or side effects of cannabis extract
- Discontinuation of cannabis extract
Conclusion The study seeks to establish the feasibility and clinical effects of a standardized cannabis extract for FM, addressing a critical gap in treatment strategies. Further research is needed to validate its efficacy and optimize FM management.
- Conditions
- Fibromyalgia (FM)
- Keywords
- fibromyalgia, cannabis, pain, fatigue, quality of life, sleep disturbances
- Medical subject headings
- Fibromyalgia, Marijuana Abuse, Pain, Fatigue, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 12 weeks among patients affected by FM
The primary endpoint is based on a comparative analysis between the Visual Analogic Scale (VAS) score reported before cannabis extract Avextra 10/10 solution and after 12 weeks of therapy. VAS will use a 100 mm pain line where 0 represents "no pain at all" and 100 is "maximum pain ever experienced".
Measured: 12 weeks
Secondary outcomes (7)
Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on sleep quality among patients affected by FM using Pittsburgh sleep quality index (PSQI)
Pittsburgh sleep quality index (PSQI) consists of 19 self-rated questions and 5 questions rated by a bed partner or roommate (if applicable).
The self-rated items are organized into seven component scores:
- Subjective Sleep Quality: Perceived sleep quality overall.
- Sleep Latency: Time taken to fall asleep.
- Sleep Duration: Total hours of actual sleep per night.
- Habitual Sleep Efficiency: Ratio of actual sleep to time spent in bed.
- Sleep Disturbances: Frequency of problems such as waking up during the night.
- Use of Sleep Medication: Frequency of use of sleeping pills or aids.
- Daytime Dysfunction: Impact of poor sleep on daily activities, such as feeling tired or having difficulty concentrating.
Each component is scored on a scale of 0 to 3, with higher scores indicating greater difficulty or poorer quality in that domain.
The seven component scores are summed to yield a global score ranging from 0 to 21.
A score of 5 or higher is generally indicative of poor sleep quality.
Measured: 4, 8 and 12 weeks
Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain using Widespread pain indexWPI
The WPI lists 19 specific body areas that are grouped anatomically (upper and lower extremities (e.g., shoulders, arms, legs), axial regions (e.g., neck, lower back), cranial and chest regions (e.g., jaw, chest)). These regions are divided into the left and right sides of the body, where applicable.
The patient indicates whether they have experienced pain in each of these areas during the past week. The response is binary (yes or no) for each area.
Each body area where pain is reported is assigned a score of 1. The scores from all 19 areas are summed to produce the WPI total score, which ranges from 0 to 19.
Measured: 4, 8 and 12 weeks
Evaluate the effect of cannabis extract Avextra 10/10 solution on the quality of life using The Italian versions of the Revised Fibromyalgia Impact Questionnaire (FIQR)
The Revised Fibromyalgia Impact Questionnaire (FIQR) is a validated, self-administered tool designed to measure the overall impact of fibromyalgia on a patient's daily life. The FIQR consists of 21 questions divided into three main domains:
- Function (9 items): assesses the patient's ability to perform daily tasks and activities.
- Overall Impact (2 items): measures the overall effect of fibromyalgia on the patient's life and how they perceive their condition.
- Symptom Severity (10 items): covers common fibromyalgia symptoms.
Each question is scored on a 0 to 10 scale, where 0 (No difficulty or symptoms) 10 (Extreme difficulty or worst symptoms).
The scores from all three domains are combined to give a total FIQR score, ranging from 0 to 100
Measured: 4, 8 and 12 weeks
Describe any adverse events or the principal reasons of drug discontinuation.
Describe any adverse events or the principal reasons of drug discontinuation.
Measured: 4,8,12 weeks
1. Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 12 weeks among patients affected by FM
Description: The secondary endpoint is based on a comparative analysis between the Visual Analogic Scale (VAS) score reported before cannabis extract Avextra 10/10 solution and after 12 weeks of therapy. VAS will use a 100 mm pain line where 0 represents "no pain at all" and 100 is "maximum pain ever experienced".
Measured: 4, 8 weeks
Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on Functional Appreciation Scale (FAS)
The Functional Appreciation Scale (FAS) is a tool designed to assess an individual's overall functionality and their ability to perform daily activities. It evaluates the impact of a condition, such as fibromyalgia, on physical, psychological, and social aspects of functioning. The scale typically captures subjective perceptions of functional limitations, providing valuable insights into the patient's quality of life and the effectiveness of therapeutic interventions
Measured: 4, 8, 12 weeks
Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on Symptom Severity Scale (SSS)
The Symptom Severity Score (SSS) is a tool used to assess the severity of symptoms in conditions like fibromyalgia. It evaluates key symptoms, including fatigue, sleep disturbances, cognitive issues, and somatic complaints, on a scale typically ranging from 0 to 3 (none to severe). The total score reflects the overall symptom burden, helping to classify and monitor the condition's severity.
Measured: 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start5 Dec 2024
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piercarlo Sarzi Puttini, Medical Doctor, Principal investigator, IRCCS Ospedale Galeazzi Sant'Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747039
- Sponsor's protocol ID
- SUNRISE (L4184)
- Acronym
- SUNRISE
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of this study will be submitted for publication to peer-reviewed journals or for presentation at national and international congresses. Each paper or abstract, must be reviewed and approved by the executive committee prior to submission. IPD will be shared upon reasonable request.
Publications
Sarzi-Puttini P, Giorgi V, Marotto D, Atzeni F. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol. 2020 Nov;16(11):645-660. doi: 10.1038/s41584-020-00506-w. Epub 2020 Oct 6.
PubMed 33024295Pozzi G, Frustaci A, Tedeschi D, Solaroli S, Grandinetti P, Di Nicola M, Janiri L. Coping strategies in a sample of anxiety patients: factorial analysis and associations with psychopathology. Brain Behav. 2015 Aug;5(8):e00351. doi: 10.1002/brb3.351. Epub 2015 Jun 24.
PubMed 26356192Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, Ferrara M, De Gennaro L. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013 Apr;34(4):511-9. doi: 10.1007/s10072-012-1085-y. Epub 2012 Apr 13.
PubMed 22526760Cerea S, Todd J, Ghisi M, Mancin P, Swami V. Psychometric properties of an Italian translation of the Functionality Appreciation Scale (FAS). Body Image. 2021 Sep;38:210-218. doi: 10.1016/j.bodyim.2021.04.007. Epub 2021 May 4.
PubMed 33962221Salaffi F, Franchignoni F, Giordano A, Ciapetti A, Sarzi-Puttini P, Ottonello M. Psychometric characteristics of the Italian version of the revised Fibromyalgia Impact Questionnaire using classical test theory and Rasch analysis. Clin Exp Rheumatol. 2013 Nov-Dec;31(6 Suppl 79):S41-9. Epub 2013 Jun 26.
PubMed 23806265Sotoodeh R, Waldman LE, Vigano A, Moride Y, Canac-Marquis M, Spilak T, Gamaoun R, Kalaba M, Hachem Y, Beaulieu P, Desroches J, Ware MA, Perez J, Shir Y, Fitzcharles MA, Martel MO. Predictors of Pain Reduction Among Fibromyalgia Patients Using Medical Cannabis: A Long-Term Prospective Cohort Study. Arthritis Care Res (Hoboken). 2023 Jul;75(7):1588-1594. doi: 10.1002/acr.24985. Epub 2023 Feb 3.
PubMed 35876631Aster HC, Evdokimov D, Braun A, Uceyler N, Sommer C. Analgesic Medication in Fibromyalgia Patients: A Cross-Sectional Study. Pain Res Manag. 2022 Sep 22;2022:1217717. doi: 10.1155/2022/1217717. eCollection 2022.
PubMed 36247103Chaves C, Bittencourt PCT, Pelegrini A. Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Pain Med. 2020 Oct 1;21(10):2212-2218. doi: 10.1093/pm/pnaa303.
PubMed 33118602Giorgi V, Bongiovanni S, Atzeni F, Marotto D, Salaffi F, Sarzi-Puttini P. Adding medical cannabis to standard analgesic treatment for fibromyalgia: a prospective observational study. Clin Exp Rheumatol. 2020 Jan-Feb;38 Suppl 123(1):53-59. Epub 2020 Feb 5.
PubMed 32116208Mazza M. Medical cannabis for the treatment of fibromyalgia syndrome: a retrospective, open-label case series. J Cannabis Res. 2021 Feb 17;3(1):4. doi: 10.1186/s42238-021-00060-6.
PubMed 33597032Kurlyandchik I, Tiralongo E, Schloss J. Safety and Efficacy of Medicinal Cannabis in the Treatment of Fibromyalgia: A Systematic Review. J Altern Complement Med. 2021 Mar;27(3):198-213. doi: 10.1089/acm.2020.0331. Epub 2020 Dec 8.
PubMed 33337931Cameron EC, Hemingway SL. Cannabinoids for fibromyalgia pain: a critical review of recent studies (2015-2019). J Cannabis Res. 2020 May 29;2(1):19. doi: 10.1186/s42238-020-00024-2.
PubMed 33526114Walitt B, Fitzcharles MA, Hassett AL, Katz RS, Hauser W, Wolfe F. The longitudinal outcome of fibromyalgia: a study of 1555 patients. J Rheumatol. 2011 Oct;38(10):2238-46. doi: 10.3899/jrheum.110026. Epub 2011 Jul 15.
PubMed 21765102Giorgi V, Sirotti S, Romano ME, Marotto D, Ablin JN, Salaffi F, Sarzi-Puttini P. Fibromyalgia: one year in review 2022. Clin Exp Rheumatol. 2022 Jun;40(6):1065-1072. doi: 10.55563/clinexprheumatol/if9gk2. Epub 2022 Jun 22.
PubMed 35748720Martinez JE, Guimaraes I. "Fibromyalgia - are there any new approaches?". Best Pract Res Clin Rheumatol. 2024 Mar;38(1):101933. doi: 10.1016/j.berh.2024.101933. Epub 2024 Feb 13.
PubMed 38355316
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ObServational StUdy of CaNnabis ExtRact in FIbromyalgia SyndromE
- ClinicalTrials.gov ID
- NCT06747039
- Acronym / sponsor ID
- SUNRISE / SUNRISE (L4184)
- Conditions
- Fibromyalgia (FM)
- Keywords
- fibromyalgia, cannabis, pain, fatigue, quality of life, sleep disturbances
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fibromyalgia (FM) is a chronic condition characterized by widespread pain, mechanical hyperalgesia, fatigue, sleep disturbances, psychological and cognitive impairments, mood changes, headaches, migraines, and gastrointestinal symptoms. Despite its recognition as a medical condition with diagnostic criteria and severity scales, its exact causes and effective treatment remain unclear. FM significantly impacts patients' quality of life and poses a societal burden due to high direct and indirect costs.
Cannabis-based treatments have gained attention for FM symptom management. In Italy, therapeutic cannabis has been legal since 2013 and may be prescribed when conventional treatments fail or cause intolerable side effects. Its primary components, tetrahydrocannabinol (THC) and cannabidiol (CBD), interact with cannabinoid receptors to potentially provide pain relief, anti-inflammatory effects, and mood stabilization.
The study aims to evaluate the efficacy of the standardized cannabis extract Avextra 10/10 (10 mg/mL THC and 10 mg/mL CBD) for FM treatment.
Objectives Primary objective: -Assess the extract's impact on pain after 12 weeks.
Secondary objective:
- Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on fatigue, sleep, anxiety and depression after 4, 8 and 12 weeks among patients affected by FM
- Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 4 and 8 weeks among patients affected by FM.
- Evaluate the effect of cannabis extract Avextra 10/10 solution on the quality of life at 4, 8 and 12 weeks among patients affected by FM.
- Describe any adverse events or the principal reasons of drug discontinuation.
Design and Methods This is a monocentric observational prospective study in which patients with FM who undertake cannabis therapy with cannabis extract Avextra 10/10 solution will consecutively be recruited.
Population: The inclusion criteria are:
- Patients with a diagnosis of FM according to 2016 American College of Rheumatology Criteria [2].
- 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.
The exclusion criteria are:
- 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
All patients with FM will undergo a standard clinical assessment, at baseline and at the follow-up visits, as part of the routine clinical practice. After the baseline visit, corresponding to the appointment where medical cannabis is prescribed within two weeks before the undertake of cannabis extract, follow-up visits will be scheduled according to routine clinical practice as follow:
- 15 days after the undertake of cannabis extract (T15)
- 30 days after the undertake of cannabis extract (T30)
- 60 days after the undertake of cannabis extract (T60)
- 90 days after the undertake of cannabis extract (T90)
- 6 months after the undertake of cannabis extract. All patients with FM will undergo a standard clinical assessment, at baseline and at the follow-up visits, as part of the routine clinical practice.
Data collected from participants during clinical evaluations at baseline visit will include:
- Demographic data: age, gender, BMI, residence
- Educational qualification
- Occupational status
- Age at menopause (if applicable)
- Current medication
- Comorbidities
- Symptom duration
- Age at FM diagnosis
- Number of sure tender point
- Smoke status
- Physical activity
Data collected from participants during clinical evaluations at follow-up visit will include:
- Number of sure tender point
- Smoke status
- Physical activity
- Efficacy or side effects of cannabis extract
- Discontinuation of cannabis extract
Conclusion The study seeks to establish the feasibility and clinical effects of a standardized cannabis extract for FM, addressing a critical gap in treatment strategies. Further research is needed to validate its efficacy and optimize FM management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients afferent to IRCCS Ospedale Galeazzi Sant- Ambrogio in Milan (Italy) with FIbromyalgia Syndrome who will start therapy with cannabis extract Avextra 10/10.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 12 weeks among patients affected by FM
Time frame: 12 weeks
The primary endpoint is based on a comparative analysis between the Visual Analogic Scale (VAS) score reported before cannabis extract Avextra 10/10 solution and after 12 weeks of therapy. VAS will use a 100 mm pain line where 0 represents "no pain at all" and 100 is "maximum pain ever experienced".
7 secondary outcomes
Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on sleep quality among patients affected by FM using Pittsburgh sleep quality index (PSQI)
Time frame: 4, 8 and 12 weeks
Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain using Widespread pain indexWPI
Time frame: 4, 8 and 12 weeks
Evaluate the effect of cannabis extract Avextra 10/10 solution on the quality of life using The Italian versions of the Revised Fibromyalgia Impact Questionnaire (FIQR)
Time frame: 4, 8 and 12 weeks
Describe any adverse events or the principal reasons of drug discontinuation.
Time frame: 4,8,12 weeks
1. Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 12 weeks among patients affected by FM
Time frame: 4, 8 weeks
Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on Functional Appreciation Scale (FAS)
Time frame: 4, 8, 12 weeks
Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on Symptom Severity Scale (SSS)
Time frame: 4, 8, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Background: PubMed 33024295Sarzi-Puttini P, Giorgi V, Marotto D, Atzeni F. Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol. 2020 Nov;16(11):645-660. doi: 10.1038/s41584-020-00506-w. Epub 2020 Oct 6.
- Background: PubMed 26356192Pozzi G, Frustaci A, Tedeschi D, Solaroli S, Grandinetti P, Di Nicola M, Janiri L. Coping strategies in a sample of anxiety patients: factorial analysis and associations with psychopathology. Brain Behav. 2015 Aug;5(8):e00351. doi: 10.1002/brb3.351. Epub 2015 Jun 24.
- Background: PubMed 22526760Curcio G, Tempesta D, Scarlata S, Marzano C, Moroni F, Rossini PM, Ferrara M, De Gennaro L. Validity of the Italian version of the Pittsburgh Sleep Quality Index (PSQI). Neurol Sci. 2013 Apr;34(4):511-9. doi: 10.1007/s10072-012-1085-y. Epub 2012 Apr 13.
- Background: PubMed 33962221Cerea S, Todd J, Ghisi M, Mancin P, Swami V. Psychometric properties of an Italian translation of the Functionality Appreciation Scale (FAS). Body Image. 2021 Sep;38:210-218. doi: 10.1016/j.bodyim.2021.04.007. Epub 2021 May 4.
- Background: PubMed 23806265Salaffi F, Franchignoni F, Giordano A, Ciapetti A, Sarzi-Puttini P, Ottonello M. Psychometric characteristics of the Italian version of the revised Fibromyalgia Impact Questionnaire using classical test theory and Rasch analysis. Clin Exp Rheumatol. 2013 Nov-Dec;31(6 Suppl 79):S41-9. Epub 2013 Jun 26.
- Background: PubMed 35876631Sotoodeh R, Waldman LE, Vigano A, Moride Y, Canac-Marquis M, Spilak T, Gamaoun R, Kalaba M, Hachem Y, Beaulieu P, Desroches J, Ware MA, Perez J, Shir Y, Fitzcharles MA, Martel MO. Predictors of Pain Reduction Among Fibromyalgia Patients Using Medical Cannabis: A Long-Term Prospective Cohort Study. Arthritis Care Res (Hoboken). 2023 Jul;75(7):1588-1594. doi: 10.1002/acr.24985. Epub 2023 Feb 3.
- Background: PubMed 36247103Aster HC, Evdokimov D, Braun A, Uceyler N, Sommer C. Analgesic Medication in Fibromyalgia Patients: A Cross-Sectional Study. Pain Res Manag. 2022 Sep 22;2022:1217717. doi: 10.1155/2022/1217717. eCollection 2022.
- Background: PubMed 33118602Chaves C, Bittencourt PCT, Pelegrini A. Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Pain Med. 2020 Oct 1;21(10):2212-2218. doi: 10.1093/pm/pnaa303.
- Background: PubMed 32116208Giorgi V, Bongiovanni S, Atzeni F, Marotto D, Salaffi F, Sarzi-Puttini P. Adding medical cannabis to standard analgesic treatment for fibromyalgia: a prospective observational study. Clin Exp Rheumatol. 2020 Jan-Feb;38 Suppl 123(1):53-59. Epub 2020 Feb 5.
- Background: PubMed 33597032Mazza M. Medical cannabis for the treatment of fibromyalgia syndrome: a retrospective, open-label case series. J Cannabis Res. 2021 Feb 17;3(1):4. doi: 10.1186/s42238-021-00060-6.
- Background: PubMed 33337931Kurlyandchik I, Tiralongo E, Schloss J. Safety and Efficacy of Medicinal Cannabis in the Treatment of Fibromyalgia: A Systematic Review. J Altern Complement Med. 2021 Mar;27(3):198-213. doi: 10.1089/acm.2020.0331. Epub 2020 Dec 8.
- Background: PubMed 33526114Cameron EC, Hemingway SL. Cannabinoids for fibromyalgia pain: a critical review of recent studies (2015-2019). J Cannabis Res. 2020 May 29;2(1):19. doi: 10.1186/s42238-020-00024-2.
- Individual participant dataSharing planned: Yes. The results of this study will be submitted for publication to peer-reviewed journals or for presentation at national and international congresses. Each paper or abstract, must be reviewed and approved by the executive committee prior to submission. IPD will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Piercarlo Sarzi Puttini, Medical Doctor contact
Piercarlo Sarzi Puttini, Medical Doctor principal investigator
IRCCS Ospedale Galeazzi Sant'Ambrogio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia (FM), run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Greta Pellegrino, Medical Doctor (0283500010 ext. 0039, greta.pellegrino@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the clinical effect of cannabis extract Avextra 10/10 solution on pain after 12 weeks among patients affected by FM (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06747039, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.