NCT05092191 Cannabis as a Complementary Treatment in Multiple Sclerosis
| NCT ID | NCT05092191 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2022-11-10 |
| Primary Completion | 2025-04-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 250 participants in total. It began in 2022-11-10 with a primary completion date of 2025-04-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Pierre Duquette, MD
PRINCIPAL INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Frequently Asked Questions
Who can join the NCT05092191 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05092191 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05092191 currently recruiting?
Yes, NCT05092191 is actively recruiting participants. Contact the research team at pierre.duquette.med@ssss.gouv.qc.ca for enrollment information.
Where is the NCT05092191 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05092191 clinical trial?
NCT05092191 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is Pierre Duquette, MD at Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 250 participants.
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