Fibromyalgia MedDRA version: 20.0 Level: LLT Classification code 10016631 Term: Fibromyalgia syndrome System Organ Class: 100000004859
Conditions
Interventions
Product Name: Cannabidiol tablet 10 mg
Product Code: None
Pharmaceutical Form:
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
The Parker Institute, Bispebjerg and Frederiksberg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Informed consent obtained Clinical diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 1990 criteria Adult individuals (Age =18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: On-going participation in other medical trials for pain management of fibromyalgia Diagnosis of Rheumatoid Arthritis or other inflammatory diseases Diagnosis of other serious chronic diseases Impaired liver and kidney function Pregnancy or insufficient anti-conception therapy for female fertile participants Planning pregnancy or insufficient anti-conception use in female fertile partners of male participants Breast feeding Surgery scheduled for the trial period or within 3 months prior to enrollment History of or current diagnosis of cancer History of or current epilepsy and seizures History of or major depressive disorder History of a suicide attempt or any suicidal behavior A mental state impeding compliance with the program History of severe psychiatric disorders History of or current abusive behavior of cannabis History of or current abusive behavior of other drugs History of or current abusive behavior of alcohol Severe personality disorder Current use of opioids, opioid antagonists (LDN) or similar strong analgesics Allergic reactions to the active ingredients in cannabidiol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of cannabidiol 50 mg compared to cannabidiolplacebo, on change in pain intensity from baseline to week 24.;Secondary Objective: To assess the effect of cannabidiol 50 mg, compared to cannabidiolplacebo, on changes in the following secondary key endpoints: Sleep quality and duration, activities of daily living, quality of life from baseline to week 24.;Primary end point(s): The primary endpoint is change in pain intensity, measured on a 0-10 Pain Numeric Rating scale (NRS) included in the revised Fibromyalgia Impact Questionnaire (FIQ-R). To facilitate interpretation of the pain intensity measure, the findings will also be communicated as the proportion of patients achieving more than 30% and 50% pain reduction on the FIQ-R Pain Numeric Rating scale.;Timepoint(s) of evaluation of this end point: From baseline to week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints are changes in: Sleep quality and duration: The Pittsburg Sleep Quality Index, subjective sleep quality and duration domains Objectively measured sleep duration and patterns: Accelerometer data Activities of daily living: The Assessment of Motor and Process Skills and Activities of Daily living-Questionnaire Quality of life: The EuroQol Group self-rated health questionnaire 5D Exploratory secondary endpoints are changes in: Sleep latency: The Pittsburg Sleep Quality Index, subjective sleep latency domains Pain self-efficacy: The Pain Self-Efficacy questionnaire Stiffness: Fibromyalgia Impact Questionnaire- revised, stiffness subscale Energy level: Fibromyalgia Impact Questionnaire- revised, energy subscale Objectively measured physical activity: Accelerometer data Feeling rested: Fibromyalgia Impact Questionnaire- revised, rested subscale Depression: Fibromyalgia Impact Questionnaire- revised, depression subscale Depression, anxiety and stress: The Depression, Anxiety, Stress Scale depression anxiety and stress scale Anxiety level: Fibromyalgia Impact Questionnaire- revised, anxiety subscale Perceived stress: The Perceived Stress Scale Cortisol concentration in hair: Hair clipping analysis Memory problems: Fibromyalgia Impact Questionnaire- revised, memory subscale Tenderness level (tenderness to touch): Fibromyalgia Impact Questionnaire- revised, tenderness subscale Balance problems: Fibromyalgia Impact Questionnaire- revised, balance subscale Environmental sensitivity: Fibromyalgia Impact Questionnaire- revised, environmental sensitivity subscale Pressure pain threshold and tolerance: Cuff algometry Appetite: The simplified nutritional appetite questionnaire Body weight Body composition: Bioimpedance Body fat distribution: Waist and hip circumferences;Timepoint(s) of evaluation of this end point: From baseline to week 24 | — |
Countries
Denmark
Contacts
Public ContactMarianne Uggen Rasmussen
The Parker Institute
Outcome results
None listed