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

NCT07023744 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: CAN-DRE
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Drug Resistant Epilepsy

Keywords

adult and children; cannabis; DRE; CBD-isolate; CBD-enriched Cannabis Herbal Extract (CHE); cannabidiol

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• participant/family acceptability of this trial design

  116 days

• Quality of Life reported by adult participant/family

  116 days

• health resource utilization and changes

  176 days

• changes in work and activity impairment affected by seizure

  116 days

• Quality of Life reported by pediatric participants and family

  116 days

Study Arms (3)

Arm 1 - Placebo Arm (MPL-012)

PLACEBO COMPARATOR

Placebo arm -\> MPL-012 oil, each mL contains 0mg CBD and 0mg THC.

Drug: Placebo

Arm 2 - CBD Isolate (MPL-015)

EXPERIMENTAL

CBD-Isolate arm -\> MPL-015 oil, each ml contains 100mg CBD and 0mg THC.

Drug: CBD Isolate

Arm 3 - CBD-CHE (MPL-016)

EXPERIMENTAL

CBD-CHE arm -\> MPL-016 oil, a CBD-enriched cannabis herbal extract, each ml contains 100mg CBD and 3mg THC.

Drug: CBD CHE

Interventions

Placebo DRUG

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.

Arm 1 - Placebo Arm (MPL-012)

CBD Isolate DRUG

CBD Isolate: MPL-015 is a CBD isolate, produced by MediPharm Labs, each mL contains 100mg CBD and 0mg THC.

Arm 2 - CBD Isolate (MPL-015)

CBD CHE DRUG

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.

Arm 3 - CBD-CHE (MPL-016)

Eligibility Criteria

• Age: 24 Months - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Diagnosis of psychogenic non-epileptic seizure
• Recent (\<30 days) change in anticonvulsant therapies including anticonvulsant medications, or settings on vagal nerve stimulator
• Ketogenic diet started within 6 months (participants stable on the ketogenic diet for more than 6 months are eligible to participate)
• Vagal nerve stimulator implanted and activated within 12 months
• Concomitant regular use of narcotics (except in emergencies and physician supervised)
• Initiation or dosage change of oral or injected steroids within 3 months
• Allergy or intolerance to compounds in trial preparations
• DRE secondary to progressive neurological disease
• 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
• History of psychotic disorders
• Uncontrolled (in the perspective of the qualified investigator) medical conditions including substance use disorders
• History or concurrent cannabis use disorder
• Unwilling or unable to use highly effective methods of contraception throughout the study period and three months post-trial, where applicable

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Research Manitoba: collaborator

MeSH Terms

Conditions

Drug Resistant Epilepsy; Marijuana Abuse

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Lauren Kelly, PhD

CONTACT

204-242-3179; lauren.kelly@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MSc, BMedSci, CCRP, Associate Professor, Dept. of Pediatrics & Child Health, University of Manitoba Scientific Director, the Canadian Collaborative for Childhood Cannabinoid Therapeutics (https://www.medcannkids.ca/)

Model Details: an early phase, triple-blind, placebo-controlled, randomized clinical trial

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 17, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 17, 2025

Record last verified: 2025-06