Cannabis as a Complementary Treatment in Multiple Sclerosis
CANSEP
Efficacy of Cannabinoids to the Current Standard Treatments on Symptom Relief in Persons With Multiple Sclerosis: Randomized Controlled Trial
3 other identifiers
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-sclerosis
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
October 25, 2021
CompletedStudy Start
First participant enrolled
November 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2025
CompletedDecember 13, 2024
December 1, 2024
2.4 years
September 1, 2021
December 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Spasticity patient reported change assessment
Patient-reported spasticity: a Numerical rating scale - 0 (No pain) to 10 (worst pain)
Change from Baseline Patient reported spasticity at 28 weeks and 16 weeks
Other Outcomes (14)
Spasticity change Clinician assessment
Change from Baseline Clinician evaluation spasticity at 28 weeks and 16 weeks
Pain change assessment
Change from Baseline pain at 28 weeks and 16 weeks
Mobility Change assessement
Change from Baseline mobility at 28 weeks and 16 weeks
- +11 more other outcomes
Study Arms (4)
CBD alone
EXPERIMENTAL* 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.
THC alone
EXPERIMENTAL* 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.
THC and CBD combined
EXPERIMENTAL* 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
PLACEBO COMPARATOR* 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
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.
Eligibility Criteria
You may qualify if:
- Participants must meet the following criteria:
- Diagnosed with MS (any subtype), for at least six months, by a MS neurologist, according to the recent version of the McDonald criteria;
- 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);
- 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;
- Aged 21 years or older;
- Ability (in the investigator's opinion) and willingness to comply with all study requirements;
- Ability to speak and read French or English (grade-nine level of language required);
You may not qualify if:
- Participants will be excluded if any of the following criteria are met:
- Concomitant disease with symptoms of spasticity, or that may have influenced their level;
- 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;
- Use of cannabis or cannabinoid-based medications within 7 days of study entry and unwillingness to abstain for the duration of the study;
- History of schizophrenia, other psychotic illness or other significant psychiatric disorder other than anxiety or depression associated with their underlying condition;
- Alcohol or substance use disorder other than nicotine;
- History of epilepsy or recurrent seizures;
- Hypersensitivity to cannabinoids or any of the excipients of the study medication;
- 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;
- Impaired renal function i.e., serum creatinine clearance lower than 50 ml/min;
- 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;
- Pregnancy or breastfeeding;
- Men with history of fertility problems and who plan to conceive at any time in the future;
- Any participant who plans to conceive either at screening or while enrolled in the study;
- Inability (or unwillingness) of women of childbearing potential and men to use a medically acceptable form of contraception throughout the study duration;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CRCHUM
Montreal, Quebec, H2X 0A9, Canada
Related Publications (1)
Zertal A, Alami Marrouni K, Arbour N, Jutras-Aswad D, Pomey MP, Rouleau I, Prat A, Larochelle C, Beaulieu P, Chamelian L, Sylvestre MP, Morin D, Ouellette JS, Frejeau N, Duquette P. Efficacy of cannabinoids compared to the current standard treatments on symptom relief in persons with multiple sclerosis (CANSEP trial): study protocol for a randomized clinical trial. Front Neurol. 2024 Jul 24;15:1440678. doi: 10.3389/fneur.2024.1440678. eCollection 2024.
PMID: 39114536DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Duquette, MD
Centre hospitalier de l'Université de Montréal (CHUM)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2021
First Posted
October 25, 2021
Study Start
November 10, 2022
Primary Completion
April 10, 2025
Study Completion
May 10, 2025
Last Updated
December 13, 2024
Record last verified: 2024-12