MGC Pharmaceuticals has received approval from Australia’s Human Research Ethics Committee (HREC) for a clinical study of CannEpil versus 100% cannabidiol (CBD) to treat severe intractable epilepsy.

The head-to-head study will randomise 100 epilepsy patients who will be treated with either CannEpil or MXP100 and monitored to record differences in product effectiveness.

CannEpil is a phytocannabinoid-derived medicine formulated by MGC using high CBD and low tetrahydrocannabinol (THC) to treat drug-resistant epilepsy, while MXP100 is the company’s CBD-only product.

The study is to be conducted in alliance with Cannabis Access Clinics and Epilepsy Action Australia and is said to be one of the first to compare low THC with 100% CBD products in this indication.

“This direct comparative head-to-head study is hoped to begin to demonstrate the increased efficacy of CannEpil.”

MGC Pharma co-founder and managing director Roby Zomer said: “This direct comparative head-to-head study on the use of phytocannabinoid derived products on the treatment of severe epilepsy is hoped to begin to demonstrate the increased efficacy of CannEpil, and is an example of MGC Pharma’s commitment to being at the forefront of research and innovation in the sector, leading to increased patient access.”

The study’s primary outcome is patient-reported outcome measures (PROM) on seizures, including duration, any rescue medicines, type, possible triggers and location of seizures, among others.

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Participants will be analysed without medication for four weeks before treatment in order to determine a baseline. They will subsequently be monitored for 12 months on either CannEpil or MXP100.

The secondary outcome of the study is Patient-Reported Outcomes Measurement Information System (PROMIS-29) for measuring physical, mental and social health, as well as self-reported well-being.

Enrolment for the study is expected to begin in the fourth quarter of this year and final results are anticipated in 24 months following initiation.

Last month, MGC Pharmaceuticals secured HREC approval to carry out a controlled trial to evaluate the effect of CannEpil on driving performance, while additionally providing safety data required for the European Medicines Agency and the Therapeutic Goods Administration product registration.