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Cannabis as a Complementary Treatment in Multiple Sclerosis

Study acronym: CANSEP
StatusRecruiting
PhasePhase 2
Started2022-11-10
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 13, 2024 (before its estimated April 10, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2024-12-10
minor
Study Status v5
Primary completion date2024-03-15→2025-04-10
Completion date2025-03-15→2025-05-10
2023-07-10
minor
Study Identification, Study Status v4
Re-verified, no change to tracked fields
2022-11-28
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-08-15→confirmed 2022-11-10
2022-08-16
minor
Study Status, Study Design, Eligibility v2
PhasePhase 3→Phase 2
Start date2021-12-15→2022-08-15
Eligibility criteria+336 characters
[...] imes 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 contracep [...] Inability to use a medically acceptable form of contraceptio [...]
2021-11-18
minor
Study Status v1
Re-verified, no change to tracked fields
2021-10-12
minor
Original filing
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 Details
NCT Number NCT05092191
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: Canadian Institutes of Health Research (CIHR), Multiple Sclerosis Society of Canada
Conditions Multiple Sclerosis
Enrollment 250 participants
Start Date 2022-11-10
Primary Completion 2025-04-10 (estimated)
Study Completion 2025-05-10 (estimated)
Updated on ClinicalTrials.gov 2024-12-13