← Back to Search

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)

Must not have

Impaired renal function i.e., serum creatinine clearance lower than 50 ml/min

History of epilepsy or recurrent seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline sleep at 28 weeks and 16 weeks

Awards & highlights

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is reduced with a creatinine clearance below 50 ml/min.

Select...

I have a history of epilepsy or seizures.

Select...

I have not had schizophrenia or other major psychiatric disorders, except for anxiety or depression due to my condition.

Select...

I have not had a botulinum toxin injection in the last 4 months and am willing to avoid them during the study.

Select...

I cannot or will not use birth control during the study.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline pain at 28 weeks and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Spasticity patient reported change assessment

Other study objectives

Anxiety/Depression change assessement

Bowel /Bladder dysfunction change assessement

Cannabis use disorder assesssment

+11 more

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.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,373 Previous Clinical Trials

26,518,992 Total Patients Enrolled

2 Trials studying Multiple Sclerosis

404 Patients Enrolled for Multiple Sclerosis

Multiple Sclerosis Society of CanadaOTHER

15 Previous Clinical Trials

797 Total Patients Enrolled

15 Trials studying Multiple Sclerosis

797 Patients Enrolled for Multiple Sclerosis

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

372 Previous Clinical Trials

130,781 Total Patients Enrolled

3 Trials studying Multiple Sclerosis

451 Patients Enrolled for Multiple Sclerosis

Media Library

Cannabis oil (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05092191 — Phase 2

Multiple Sclerosis Research Study Groups: THC alone, CBD alone, THC and CBD combined, Placebo

Multiple Sclerosis Clinical Trial 2023: Cannabis oil Highlights & Side Effects. Trial Name: NCT05092191 — Phase 2

Cannabis oil (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05092191 — Phase 2

~88 spots leftby Sep 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.