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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 pain 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 below
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I am 21 years old or older.
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My MS-related muscle stiffness has been severe for over a month and current treatments aren't helping.
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I have been diagnosed with MS for at least six months.

CANSEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cannabis use disorder : assessment at only baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and cannabis use disorder : assessment at only baseline for reporting.

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 more

CANSEP 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.

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,750,858 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
365 Previous Clinical Trials
129,059 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: CBD alone, THC 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the participant pool for this trial growing?

"Absolutely. As outlined on clinicaltrials.gov, this medical research is presently recruiting candidates for the study which was initially announced on November 10th 2022 and recently updated on November 28th 2022. The aim of the trial is to enrol 250 participants from a single site."

Answered by AI

Are there any vacancies for participation in this clinical trial?

"According to the info hosted on clinicaltrials.gov, this investigation is actively seeking out participants as it was initially published on November 10th 2022 with its most recent edition made available since November 28th of that same year."

Answered by AI

Has the FDA granted single-compound CBD official endorsement?

"With a score of 2, our team at Power assesses the safety profile of CBD to be moderate. This is due to preliminary findings from Phase 2 trials that indicate some degree of safety but lack evidence for efficacy."

Answered by AI
~107 spots leftby Mar 2025