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

NCT ID: NCT07023744

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1 - Placebo Arm (MPL-012)

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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 2 - CBD Isolate (MPL-015)

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

Group Type: EXPERIMENTAL

CBD Isolate

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

CBD CHE

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

CBD Isolate

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Research Manitoba

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Lauren Kelly

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/)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Lauren Kelly, PhD

Role: CONTACT

lauren.kelly@umanitoba.ca

204-242-3179

Other Identifiers

CAN-DRE

Identifier Type: -

Identifier Source: org_study_id