Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study (SUNRISE)

December 18, 2024 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milano, Italy, 20157
        • Recruiting
        • IRCCS Ospedale Galeazzi-Sant'Ambrogio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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.
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

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.
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

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
4, 8 and 12 weeks
Describe any adverse events or the principal reasons of drug discontinuation.
Time Frame: 4,8,12 weeks
Describe any adverse events or the principal reasons of drug discontinuation.
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
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".
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
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
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
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.
4, 8, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Investigators

  • Principal Investigator: Piercarlo Sarzi Puttini, Medical Doctor, IRCCS Ospedale Galeazzi Sant'Ambrogio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 18, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUNRISE (L4184)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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