Grant: Project Grant

Close to 300,000 people in Canada have epilepsy, and more than 30% of people with epilepsy do not respond well to conventional therapies. Drug-resistant epilepsy (DRE) is when people do not respond to several seizure medications and is challenging for clinicians, patients, and caregivers. In the United States, Europe, and Australia, cannabidiol (CBD) has been approved as a medicine to reduce seizures in children and adults with DRE. In Canada, no purified CBD product is available by prescription, and small studies have shown that CBD-enriched cannabis products (with small amounts of THC) may have greater benefits in reducing seizures at lower doses. No study has compared these products head-to-head, so it is unclear if CBD works better alone or in combination with THC to reduce seizures in people with DRE. Our clinical trial is looking at CBD and CBD-enriched cannabis products for children and adults with DRE. We will recruit 90 participants over 12 months across 8 sites. Participants and researchers will not know if they get CBD alone, CBD and THC, or placebo until the end of the trial (140 days). Patient-centred organizations have partnered with a pediatric medical cannabis research team (C4T) and a research team with expertise in adult epilepsy clinical trials (EpLink) to answer this important question. This trial is led by experts in pediatric and adult neurology, and clinical trials meeting all regulatory requirements for studying medicines and cannabis products for health purposes. CAN-DRE is guided by an international steering committee, an independent data safety monitoring board, people with lived experience, and several patient-centred advocacy organizations. The results from this study will be directly shared with the public following an extensive knowledge mobilization plan developed with policy makers to inform clinical practice guidelines.