Effect of Cannabinoids on Pain in Fabry Disease Patients

Launched by ALBINA NOWAK, MD · Mar 24, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a medication called Sativex® on neuropathic pain in patients with Fabry Disease, a rare genetic condition that can cause severe pain due to nerve damage. Many people with Fabry Disease experience ongoing pain that is hard to treat with standard medications, often leading to the need for strong painkillers. Sativex® is an oral spray that contains two compounds from the cannabis plant, THC and CBD, which have been helpful in managing pain for other conditions. The goal of this study is to see if Sativex® can provide better relief for Fabry patients suffering from neuropathic pain.

To participate in this trial, individuals must be between 18 and 70 years old, have a confirmed diagnosis of Fabry Disease, and be receiving enzyme replacement therapy. They should have been experiencing pain for at least three months and have a specific level of pain intensity. Participants will need to be able to speak German and provide informed consent. It's important to note that certain individuals, such as pregnant women or those with specific medical conditions, may not be eligible. If you qualify and choose to participate, you will be closely monitored throughout the trial to assess the effectiveness of the treatment on your pain.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • • Age: 18-70 years
• • Patients with genetically confirmed Fabry disease
• • On treatment with Enzyme Replacement Therapy (ERT)
• • Sufficient command of German language
• • Pain duration of more than 3 months
• • Stable analgesic regimen for at least 2 weeks preceding the study entry day
• • Baseline worst last week pain intensity ≥4 on numerical rating scale (NRS)
• • Signed and dated informed consent
• • ERT or chaperone therapy at a stable dose for at least 3 last months
• Exclusion Criteria:
• • • Known hypersensitivity or allergy to cannabinoids.
• • Women who are pregnant or breast feeding; intention to become pregnant during the course of the study, lack of safe contraception, defined as: female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not willing or able to use any other second (additional) considered sufficiently reliable by the investigator in individual cases. Female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
• • Dementia
• • Other pain not of neuropathic origin thought by the investigator to be of nature or severity to interfere with the patient's assessment of neuropathic pain due to Fabry disease.
• • Patients with known or suspected non-compliance, drug or alcohol abuse, including Marijuana cigarettes.
• • Patients with known schizophrenia, other psychotic disorders, personality disorders or another severe psychiatric disorder or positive family history with these disorders, except depression.
• • Patients with another clinically significant disease (e.g. renal failure, hepatic dysfunction, severe cardiovascular or convulsive diseases).
• • Participation in another study with investigational drugs within the 30 days preceding and during the present study.
• • Previous enrolment into the current study
• • Enrolment of the investigator, his/her family members, employees and other dependent persons.