A Phase 2 interventional study of Placebo and CBD Isolate in Drug Resistant Epilepsy, sponsored by University of Manitoba. Not yet recruiting. Open to participants aged 24 Months to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by University of Manitoba · Phase 2, Interventional, and Treatment
Epilepsy is a neurological disorder affecting more than 50 million people globally, including more than 260,000 Canadians. Cannabidiol (CBD) reduces seizure frequency and improves quality of life for adults and children with Drug Resistant Epilepsy (DRE). Several uncontrolled, small, open label studies reported that CBD-enriched Cannabis Herbal Extract (CHE) resulted in a reduction of seizure frequency, but we lack critical information on efficacy, comparative effectiveness and dosing of CBD and ∆9-tetrahydrocannabinol (THC) in children and adults with DRE. CAN-DRE is an early phase, triple-blind, placebo-controlled, randomized clinical trial to answer the questions of if cannabinoids work to reduce seizures in children and adults (24 months to 55 years) with DRE and if CBD works better in an isolate or in a CBD-enriched Cannabis Herbal Extract. The primary outcome of CAN-DRE is reported monthly seizure count from baseline to maintenance phase.
261 studies on the registry are indexed under Drug Resistant Epilepsy; 99 are open to participants now.
This study's planned enrollment of 90 is above the median of 30 across 208 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo arm -\> MPL-012 oil, each mL contains 0mg CBD and 0mg THC.
Drug: Placebo
CBD-Isolate arm -\> MPL-015 oil, each ml contains 100mg CBD and 0mg THC.
Drug: CBD Isolate
CBD-CHE arm -\> MPL-016 oil, a CBD-enriched cannabis herbal extract, each ml contains 100mg CBD and 3mg THC.
Drug: CBD CHE
Placebo arm: participants will receive Placebo MPL-012 oil only through the trial participation. MPL-012 is produced by MediPharm Labs, each mL contains 0mg CBD and 0mg THC.
CBD Isolate: MPL-015 is a CBD isolate, produced by MediPharm Labs, each mL contains 100mg CBD and 0mg THC.
CBD-CHE arm: MPL -016 is a CBD-enriched cannabis herbal extract, produced by MediPharm Labs, each mL contains 100mg of CBD and 3mg of THC.
Efficacy in reducing seizure frequency
reported monthly seizure count from baseline to maintenance
Time frame: 116 days
Cannabinoid-related AEs and DLTs
The frequency and type of adverse events and dose limiting toxicities (DLTs) reported by caregivers and participants throughout the trial participation
Time frame: 116 + 60 days
participant/family acceptability of this trial design
to be measured via post-study questionnaire, open-ended questions asked, no specific scale is used.
Time frame: 116 days
Quality of Life reported by adult participant/family
Quality of Life in Epilepsy Inventory (QOLIE-31) tool for adult participants. Changes from baseline to maintenance phase will be compared to measure the outcome.
Time frame: 116 days
health resource utilization and changes
A trial-specific Health Resource Utilization Questionnaire (HRUQ) is used to collect epilepsy participants' healthcare resource usage and out-of-pocket healthcare expenses during trial participation. The data will be analyzed descriptively to measure direct and indirect healthcare resource utilization related to the intervention from baseline phase to 60-day follow up post study protocolized treatment.
Time frame: 176 days
changes in work and activity impairment affected by seizure
WPAI (Work Productivity and Activity Impairment Questionnaire) asks about the effect of participant's seizure on their/their caregivers' ability to work and perform regular activities. Changes reported from baseline to maintenance phase will be compared.
Time frame: 116 days
Quality of Life reported by pediatric participants and family
Quality of Life in Childhood Epilepsy (QOLCE-55) tool for pediatric participants (4 - 17 yrs). Changes from baseline to maintenance phase will be compared to measure the outcome.
Time frame: 116 days
No study locations are listed for this record.
Plan to share: Undecided — No, summary level data may be available from the CAN-DRE steering committee following research ethics board approval.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University of Manitoba