Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study

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".

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.

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.

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

Describe any adverse events or the principal reasons of drug discontinuation.

Describe any adverse events or the principal reasons of drug discontinuation.