CANnabinoids for Drug Resistant Epilepsy (DRE) in Adults and Children (CAN-DRE)

A Triple-Blind, Placebo-Controlled, Randomized Clinical Trial of CANnabinoids for Drug Resistant Epilepsy in Adults and Children

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Drug Resistant Epilepsy
• Intervention / Treatment: Drug: Placebo; Drug: CBD Isolate; Drug: CBD CHE

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lauren Kelly, PhD; Phone Number: 204-242-3179; Email: lauren.kelly@umanitoba.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ages 24 months to 55 years old at the time of enrollment
2. Diagnosed with DRE: not achieved seizure freedom, with adequate trials of 2 antiseizure medications 29
3. Medical history of 4 + clinically recognizable seizures (any type with clusters counted as a single event) per month
4. Have a negative pregnancy test at screening for patients who have experienced menarche
5. Agree to abstain from driving and recreational cannabis use throughout the study

Exclusion Criteria:

1. Diagnosis of psychogenic non-epileptic seizure
2. Recent (<30 days) change in anticonvulsant therapies including anticonvulsant medications, or settings on vagal nerve stimulator
3. Ketogenic diet started within 6 months (participants stable on the ketogenic diet for more than 6 months are eligible to participate)
4. Vagal nerve stimulator implanted and activated within 12 months
5. Concomitant regular use of narcotics (except in emergencies and physician supervised)
6. Initiation or dosage change of oral or injected steroids within 3 months
7. Allergy or intolerance to compounds in trial preparations
8. DRE secondary to progressive neurological disease
9. Clinically significant cardiac, renal or hepatic disease (as assessed by site investigator); elevated liver enzymes (GGT and/or AST and/or ALT) or lipase >3 times upper limit, adjusted for age
10. History of psychotic disorders
11. Uncontrolled (in the perspective of the qualified investigator) medical conditions including substance use disorders
12. History or concurrent cannabis use disorder
13. Unwilling or unable to use highly effective methods of contraception throughout the study period and three months post-trial, where applicable

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 1 - Placebo Arm (MPL-012); Placebo arm -> MPL-012 oil, each mL contains 0mg CBD and 0mg THC.	Drug: Placebo; 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.
Experimental: Arm 2 - CBD Isolate (MPL-015); CBD-Isolate arm -> MPL-015 oil, each ml contains 100mg CBD and 0mg THC.	Drug: CBD Isolate; CBD Isolate: MPL-015 is a CBD isolate, produced by MediPharm Labs, each mL contains 100mg CBD and 0mg THC.
Experimental: Arm 3 - CBD-CHE (MPL-016); CBD-CHE arm -> MPL-016 oil, a CBD-enriched cannabis herbal extract, each ml contains 100mg CBD and 3mg THC.	Drug: CBD CHE; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy in reducing seizure frequency	reported monthly seizure count from baseline to maintenance	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	116 + 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
participant/family acceptability of this trial design	to be measured via post-study questionnaire, open-ended questions asked, no specific scale is used.	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.	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.	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.	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.	116 days

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Canadian Institutes of Health Research (CIHR); Research Manitoba

Study record dates

Study Major Dates

• Study Start (Estimated): July 27, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: May 22, 2025
• First Submitted That Met QC Criteria: June 13, 2025
• First Posted (Actual): June 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: cannabis; cannabidiol; DRE; adult and children; CBD-isolate; CBD-enriched Cannabis Herbal Extract (CHE)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Epilepsy; Drug Resistant Epilepsy; Marijuana Abuse
• Other Study ID Numbers: CAN-DRE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No, summary level data may be available from the CAN-DRE steering committee following research ethics board approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No