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

Launched by UNIVERSITY OF MANITOBA · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether certain cannabis-based treatments can help reduce seizures in people with drug-resistant epilepsy (DRE), a condition where seizures don’t improve despite trying at least two different seizure medications. The study is looking at both children (as young as 2 years old) and adults up to 55 years old. Researchers want to find out if cannabidiol (CBD), a compound found in cannabis, helps lower the number of seizures, and whether pure CBD works better than a special cannabis extract that contains both CBD and a small amount of THC (another cannabis compound).

People who might join this study need to have ongoing seizures despite treatment, with at least four noticeable seizures each month. Participants will be asked to avoid driving and using recreational cannabis during the trial. The study will carefully compare the effects of different cannabis treatments against a placebo (a harmless, inactive substance) in a way that neither the participants nor the researchers will know who is receiving which treatment until the study ends. This helps ensure the results are fair and reliable. If you or your family member fits these criteria and are interested, this study hopes to provide clearer answers about how cannabis-based treatments might help control seizures in drug-resistant epilepsy.

Gender

ALL

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