Medical Cannabis for Fibromyalgia

Phase 1

• Conditions: Fibromyalgia; MedDRA version: 20.0Level: LLTClassification code 10016631Term: Fibromyalgia syndromeSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-002394-59-DK
• Lead Sponsor: The Parker Institute, Bispebjerg and Frederiksberg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-08
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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 <75 years)
Average pain intensity = 4 on a Numeric Rating Scale (NRS)
No use of medical cannabis (THC/CBD) within the last six months
Proficiency in spoken Danish language and able to read and write in
Danish
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified