MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) has welcomed positive results from a recent study investigating the effects of its epilepsy treatment, CannEpil®, on vehicle driving performance, sedation and mood.
Notably, the results demonstrated that CannEpil was safe for post-treatment driving activities.
The clinical study included the use of a driving simulator, a technique used to collect data required for drug labelling when pre and early clinical studies indicate that a drug may cause somnolence or impair cognition.
Looking ahead, the results of the study will be used to support safety data from future clinical trials when preparing submission packages for regulatory agencies.
Study highlights
The trial assessed 31 healthy, fully licensed drivers (15 male, 16 female) aged between 21 and 58 years with a median age of 36 years of age.
Participants consumed either CannEpil or a placebo, and 90 minutes later completed a 40-minute “highway” drive using a driving simulator used to assess performance outcomes for deviation of lateral position or speed, and steering variability.
Mood states and sedation levels were assessed, using the Bond-Lader visual analogue scale and Profile of the Mood States technique, both before and after the driving task.
The results of the study are outlined below:
- oral doses of 20:1 CBD to Δ9-THC did not impair overall vehicle weaving, and the standard deviation of lateral position (SDLP) was not significantly altered in those administered CannEpil compared with placebo across the full drive;
- the standard deviation of speed (SDS) was not increased within 20 minutes of driving;
- sedation was not significantly increased during testing following CannEpil administration, however, the onset of increased sedation was reported by several participants between three to six hours after CannEpil was administered; and
- ‘contentedness’, measured by the Bond-Lader Visual Analogue Scale and Profile of Mood States, was significantly increased following the driving task in those patients administered CannEpil.
About CannEpil
The CannEpil formulation is designed to treat drug-resistant epilepsy with a high-CBD, low-THC formulation and incorporates Graft Polymer's trademarked GraftBio self-nano emulsifying drug delivery system.
Epilepsy is one of the most common yet serious neurological conditions, with approximately 33% of adults, and 20 to 25% of children with epilepsy suffering from refractory epilepsy, which cannot be controlled with traditional anti-seizure medication.
The trial, sponsored by Cannvalate Australia, was undertaken by the Centre of Human Psychopharmacology at Swinburne University of Technology under the auspices of the Medical Cannabis Research Collaboration.