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Cannabinoid
Cannabis for Multiple Sclerosis (CANSEP Trial)
Phase 2
Recruiting
Led By Pierre Duquette, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 21 years or older
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline sleep at 28 weeks and 16 weeks
Awards & highlights
CANSEP Trial Summary
This trialwill assess the effects of cannabis on MS symptoms, such as spasticity, pain, and fatigue.
Who is the study for?
This trial is for adults over 21 with Multiple Sclerosis (MS) who experience spasticity not relieved by current therapy. Participants must have stable MS treatments for the last 30 days and be able to follow study procedures. They should not have severe psychiatric disorders, substance abuse issues, significant liver or heart problems, or plans to conceive.Check my eligibility
What is being tested?
The study tests whether cannabis oil containing different doses of THC alone, CBD alone, or both combined can help relieve spasticity in MS compared to a placebo. The effectiveness of these cannabinoids on symptoms like pain and cognitive abilities will also be evaluated.See study design
What are the potential side effects?
Potential side effects may include dizziness, dry mouth, changes in appetite or mood swings due to THC; CBD might cause fatigue or diarrhea. Side effects vary from person to person based on individual reactions.
CANSEP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
Select...
My MS-related muscle stiffness has been severe for over a month and current treatments aren't helping.
Select...
I have been diagnosed with MS for at least six months.
CANSEP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline pain at 28 weeks and 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline pain at 28 weeks and 16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Spasticity patient reported change assessment
Other outcome measures
Anxiety/Depression change assessement
Bowel /Bladder dysfunction change assessement
Cannabis use disorder assesssment
+11 moreCANSEP Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: THC and CBD combinedExperimental Treatment1 Intervention
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.
Group II: THC aloneExperimental Treatment1 Intervention
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.
Group III: CBD aloneExperimental Treatment1 Intervention
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.
Group IV: PlaceboPlacebo Group1 Intervention
Dosage form : Softgel
Dosage & frequency : caps of placebo twice a day
Duration : 4 weeks of treatment followed by 12 additional weeks of follow up.
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Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,351 Previous Clinical Trials
26,459,061 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
404 Patients Enrolled for Multiple Sclerosis
Multiple Sclerosis Society of CanadaOTHER
14 Previous Clinical Trials
751 Total Patients Enrolled
14 Trials studying Multiple Sclerosis
751 Patients Enrolled for Multiple Sclerosis
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
370 Previous Clinical Trials
129,619 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
451 Patients Enrolled for Multiple Sclerosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is reduced with a creatinine clearance below 50 ml/min.My liver isn't working well, as shown by tests being three times above the normal limit.I am a man with fertility issues and plan to have children in the future.I can speak and read English or French at a ninth-grade level.I am 21 years old or older.I have a history of epilepsy or seizures.My MS-related muscle stiffness has been severe for over a month and current treatments aren't helping.I have not had schizophrenia or other major psychiatric disorders, except for anxiety or depression due to my condition.I haven't had serious heart problems in the last year.I do not have any health conditions that could risk my safety or affect the study's results.I've been on a stable dose of my current medication for at least 30 days.I have not had a botulinum toxin injection in the last 4 months and am willing to avoid them during the study.I have a condition that causes muscle stiffness or affects my muscle control.I have been diagnosed with MS for at least six months.I cannot or will not use birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: THC alone
- Group 2: CBD alone
- Group 3: THC and CBD combined
- Group 4: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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