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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

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Cannabis as a Complementary Treatment in Multiple Sclerosis

Study Purpose

Multiple sclerosis (MS) is an inflammatory disease of the central nervous system (CNS) afflicting over 77,000 Canadians. Unfortunately, the therapeutic arsenal to relieve MS symptoms is limited. It is therefore essential to develop better approaches to treat the symptoms of MS. The use of cannabis for recreational purposes is now legal in Canada. However, for many years, people with Multiple Sclerosis (PwMS) have used cannabis either to relax, to reduce pain and spasticity, or to improve sleep and daily functioning. Currently, there is little scientifically established evidence that cannabis works on these symptoms in people with MS. It is therefore important to carry out studies to better understand the efficacy Δ-9-tetrahydrocannabinol (THC), and cannabidiol (CBD) on MS symptoms . THC is known for its analgesic, neuroprotective and anti-inflammatory properties and CBD seems to have positive effects on anxiety and cognitive abilities (memory, concentration). For this study, investigators hypothesize that administering different doses of THC alone, CBD alone, and THC and CBD combined will result in a significant beneficial effect on spasticity relief compared to placebo.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Participants must meet the following criteria: 1. Diagnosed with MS (any subtype), for at least six months, by a MS neurologist, according to the recent version of the McDonald criteria; 2. Spasticity due to MS of at least one-month duration and not relieved with current therapy, at a level of 4 or more on the numerical rating scale (NRS); 3. Stable dose of standard therapies for at least 30 days prior to the screening visit and willingness for these to be maintained for the duration of the study; 4. Aged 21 years or older; 5. Ability (in the investigator's opinion) and willingness to comply with all study requirements; 6. Ability to speak and read French or English (grade-nine level of language required);

Exclusion Criteria:

Participants will be excluded if any of the following criteria are met: 1. Concomitant disease with symptoms of spasticity, or that may have influenced their level; 2. Received a botulinum toxin injection within four months prior to the screening visit or unwillingness to stop receiving botulinum toxin injections for the duration of the study; 3. Use of cannabis or cannabinoid-based medications within 7 days of study entry and unwillingness to abstain for the duration of the study; 4. History of schizophrenia, other psychotic illness or other significant psychiatric disorder other than anxiety or depression associated with their underlying condition; 5. Alcohol or substance use disorder other than nicotine; 6. History of epilepsy or recurrent seizures; 7. Hypersensitivity to cannabinoids or any of the excipients of the study medication; 8. Clinically relevant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction; 9. Impaired renal function i.e., serum creatinine clearance lower than 50 ml/min; 10. Significantly impaired hepatic function, at visit 1, in the investigator's opinion and/or had liver function tests of equal to or greater than three times the upper limit of normal; 11. Pregnancy or breastfeeding; 12. Men with history of fertility problems and who plan to conceive at any time in the future; 13. Any participant who plans to conceive either at screening or while enrolled in the study; 14. Inability (or unwillingness) of women of childbearing potential and men to use a medically acceptable form of contraception throughout the study duration; 15. Inability to use a medically acceptable form of contraception throughout the study duration; m) any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject's ability to participate in the study; 16. Intention to travel internationally, or to donate blood during the study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05092191
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre hospitalier de l'Université de Montréal (CHUM)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pierre Duquette, MD
Principal Investigator Affiliation Centre hospitalier de l'Université de Montréal (CHUM)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis
Additional Details

The aim of this study is to document, 1. The efficacy of THC and CBD, alone and in combination, as add-on therapies to the current standard treatments for relief of spasticity and other symptoms in PwMS (muscle spasms and stiffness); 2. Assess the tolerability profile of THC and CBD, alone and in combination, when used in PwMS; 3. Identify the mechanisms underlying such therapeutic and adverse effects of different types of cannabis-based medicines in PwMS, Participants will initially receive THC 4mg/day or CBD 40mg/day or THC/CBD combination (THC 4mg and CBD 40mg/day), or placebo, on the first day. Dose will be increased up to 20mg (THC) and 200mg (CBD) per day, if well tolerated. Participants will receive the allocated treatment for a total of 4 weeks, followed by an additional 12 weeks of treatment for responders who will be identified as patients who had a decrease from baseline in spasticity of at least one point on the Numerical Rating Scale . THC and CBD will be taken as oil softgels in two divided doses per day. Cannabis extract and placebo will taste and look exactly the same. To protect from all contingencies and to minimize the risk of adverse reactions, the presence of adverse events will be evaluated at each research visit, as well as through courtesy calls between visits. If any mental or physical symptoms occur that require medical attention, the PwMS will be referred as required to an attending neurologist, psychiatrist, or other specialists .

Arms & Interventions

Arms

Experimental: CBD alone

Dosage form : Softgel Dosage & frequency : 40 mg /day of CBD up to 200 mg in two doses a day Duration : 4 weeks of treatment followed by 12 additional weeks of follow up.

Experimental: THC alone

Dosage form : Softgel Dosage & frequency : 4 mg /day of THC up to 20 mg in two doses a day Duration : 4 weeks of treatment followed by 12 additional weeks of follow up.

Experimental: THC and CBD combined

Dosage form : Softgel Dosage & frequency : 40 mg /day of CBD up to 200 mg and 4 mg /day of THC up to 20 mg in two doses a day Duration : 4 weeks of treatment followed by 12 additional weeks of follow up.

Placebo Comparator: Placebo

Dosage form : Softgel Dosage & frequency : caps of placebo twice a day Duration : 4 weeks of treatment followed by 12 additional weeks of follow up.

Interventions

Drug: - Cannabis oil vs placebo

Eligibility, Screening and Baseline (T0): Candidates will be seen by both research staff and a neurologist. Full written informed consent will be obtained before completing questionnaires and administering physical and medical evaluations. If eligibility is confirmed, a blood sample will be collected followed by participant randomisation . Follow-up visits: Randomized participants come back after 4 weeks (T1) for the same assessments administered at T0. Only participants who had a decrease in their level of spasticity can continue their participation in the same allocated arm for an additional period of 12 weeks. At the end of the additional period of 12 weeks (T2), another visit is scheduled for a last assessments which are the same as T0 and T1. Throughout study, courtesy calls will be scheduled and standard care for MS will also be offered to ensure participants 'safety and well-being.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CRCHUM, Montreal, Quebec, Canada

Status

Recruiting

Address

CRCHUM

Montreal, Quebec, H2X 0A9

Site Contact

Amel, Zertal (Project Manager)

[email protected]

15148908000 #30883

Nearest Location

Site Contact

Amel, Zertal (Project Manager)

[email protected]

15148908000 #30883


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

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NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

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Visit NARCOMS

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If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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