MGC Pharmaceuticals has received Human Research Ethics Committee approval to conduct a head-to-head clinical study to compare the effectiveness of its low tetrahydrocannabinol formula for the treatment of drug-resistant epilepsy to its 100% cannabidiol product.
The low tetrahydrocannabinol product is a proprietary pharmaceutical-grade phytocannabinoid-derived medicine authorized for prescription as an Investigational Medicinal Product in Australia and the UK, while the 100% cannabidiol product is currently available under Australia’s Special Access Scheme.
Management said the study, which will be carried out together with Cannabis Access Clinics and Epilepsy Action Australia, will be one of the first clinical opportunities in the world to assess and collect several data points.
These data points include the long-term safety of tetrahydrocannabinol treatments, the efficacy of cannabinoid treatments compared to currently available treatments and doctors’ assessments on cannabinoid medicine’s long-term impact on the quality of treatment and quality of life.
MGC said the study would be carried out on 100 patients from Cannabis Access Clinics for 12 months.