NCT07023744

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 24 Months – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2025-06-17
• Last updated: 2025-06-17