Effects of oral cannabidiol (CBD) usage on variable severity of spasticity in multiple sclerosis patients with gait problem caused by their spasticity. A Double-Blind Randomised Controlled Trial

Determining the effects of oral Cannabidiol administration on the severity of spasticity in multiple sclerosis (MS) patients with gait disorder due to spasticity

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 30 patients in each group. A table of random numbers has been used for randomization.

This study will be conducted in several centers in the cities of Mashhad, Tehran and Sari. The main center will be the neurology clinic of Qhaem Hospital of Mashhad University of Medical Sciences, and the patients will be given Cannabidiol oral drops and placebo. Cannabidiol starts at 2.5 mg (twice a day) and up to 35 mg in the first week, and if there is no adequate response, it will be increased to the tolerance level, and they will be followed up to 8 weeks after the start of consumption. Questionnaires of fatigue, quality of walking, urinary frequency, sleep, and pain will be measured before starting the drug and after 4 and 8 weeks from the start. Also, the patient's quality of life will be measured using EuroQoL before and after 8 weeks of the intervention. In addition, telephone follow-up of patients once every two weeks will be considered.

The condition of entering the patient is a definite diagnosis of MS based on McDonald's criteria and gait disorder, the conditions of non-entry include pregnancy, a history of using cannabis derivatives, taking drugs with liver metabolism, or suffering from liver dysfunction.

Patients are divided into two intervention and placebo groups, each of these groups receives a specific dose (40 mg/ml) of the oral solution of the drug or placebo from Khosro Medisa Teb Company.

The intensity of the patient's spasticity based on the Numeric rating scale

According to the arrival time of the patients, the patient himself draws a number from 1 to 60. These numbers are defined by the main analyzer in the pre-prepared tables as placebo or the main drug. In addition, the arrangement of numbers and drugs has been randomized once by the main analyzer as a lottery. We have 60 patients divided into two groups (i.e. original drug and placebo). Therefore, out of 60 numbers, 30 numbers belong to patients (cases) and 30 numbers belong to controls. We write the name of the case or control on the paper and put them in an open box and randomly 60 patients choose them and do not see the result and give us the paper.

Study participants will all be unaware of the group, despite being assured that they will be taking part in a study that will take either drug or placebo. Also, due to the completely similar label and specifications on the medicine bottle and placebo, the color, taste and consistency of the contents of the box are also completely blinded. Medicines are given in unmarked packages and shown to the clinical caregiver who is not in the process of treating the patients.

The data of the study participants will be evaluated for statistical analysis, and their results will be published in the form of an article.

Immediately after the publication of the results in the form of a scientific article, the results of data analysis will be available to researchers at the request of the data.

Researchers of this project and individuals who have the right to access the project data based on the written permission of the corresponding researcher can access the project data.

If the permission of the main researcher of the project is obtained with an acceptable justification and explanation, the data obtained from this project can be used.

MS Clinic, Ghaem Hospital Mashhad

A written request will be sent to the researcher in charge of the study with appropriate evidence and justification; Once approved by him, access to data and documents will be possible.