A randomised, placebo-controlled, double blind, crossover trial on the effect of a 20:1 cannabidiol: Δ9-tetrahydrocannabinol medical cannabis product on neurocognition, attention, and mood

Article

作者: Hayley, Amie C ; Stough, Con ; Catchlove, Sarah ; Manning, Brooke ; Downey, Luke A

As cannabinoid-based medications gain popularity in the treatment of refractory medical conditions, it is crucial to examine the neurocognitive effects of commonly prescribed products to ensure associated safety profiles. The present study aims to investigate the acute effects of a standard 1 mL sublingual dose of CannEpil®, a medicinal cannabis oil containing 100 mg cannabidiol (CBD) and 5 mg Δ9-tetrahydrocannabinol (THC) on neurocognition, attention, and mood. A randomised, double-blind, placebo-controlled, within-subjects design assessed 31 healthy participants (16 female, 15 male), aged between 21 and 58 years, over a two-week experimental protocol. Neurocognitive performance outcomes were assessed using the Cambridge Neuropsychological Test Automated Battery, with the Profile of Mood States questionnaire, and the Bond-Lader Visual Analogue Scale used to assess subjective state and mood. CannEpil increased Total Errors in Spatial Span and Correct Latency (median) in Pattern Recognition Memory, while also increasing Efficiency Score (lower score indicates greater efficiency) relative to placebo (all p < .05). Subjective Contentedness (p < .01) and Amicability (p < .05) were also increased at around 2.5 h post dosing, relative to placebo. Drowsiness or sedative effect was reported by 23 % of participants between three to six hours post CannEpil administration. Plasma concentrations of CBD, THC, and their metabolites were not significantly correlated with any observed alterations in neurocognition, subjective state, or adverse event occurrence. An acute dose of CannEpil impairs select aspects of visuospatial working memory and delayed pattern recognition, while largely preserving mood states among healthy individuals. Intermittent reports of drowsiness and sedation underscore the inter-individual variability of medicinal cannabis effects on subjective state. (ANZCTR; ACTRN12619000932167; https://www.anzctr.org.au).

2023-05-01·Journal of Psychopharmacology

Effect of CannEpil^® on simulated driving performance and co-monitoring of ocular activity: A randomised controlled trial

Article

作者: Stough, Con ; Shiferaw, Brook ; Manning, Brooke ; Catchlove, Sarah ; Hayley, Amie C ; Downey, Luke A

Background: Medicinal cannabis products containing Δ9-tetrahydrocannabinol (THC) are increasingly accessible. Yet, policy guidelines regarding fitness to drive are lacking, and cannabinoid-specific indexations of impairment are underdeveloped. Aims: To determine the impact of a standardised 1 mL sublingual dose of CannEpil®, a medicinal cannabis oil containing 100 mg cannabidiol (CBD) and 5 mg THC on simulated driving performance, relative to placebo and whether variations in vehicle control can be indexed by ocular activity. Methods: A double-blind, within-subjects, randomised, placebo-controlled, crossover trial assessed 31 healthy fully licensed drivers (15 male, 16 female) aged between 21 and 58 years ( M = 38.0, SD = 10.78). Standard deviation of lateral position (SDLP), standard deviation of speed (SDS) and steering variability were assessed over time and as a function of treatment during a 40 min simulated drive, with oculomotor parameters assessed simultaneously. Oral fluid and plasma were collected at 30 min and 2.5 h. Results: CannEpil did not significantly alter SDLP across the full drive, although increased SDLP was observed between 20 and 30 min ( p < 0.05). CannEpil increased SDS across the full drive ( p < 0.05), with variance greatest at 20–30 min ( p < 0.001). CannEpil increased fixation duration ( p < 0.05), blink rate (trend p = 0.051) and decreased blink duration ( p < 0.001) during driving. No significant correlations were observed between biological matrices and performance outcomes. Conclusions: CannEpil impairs select aspects of vehicle control (speed and weaving) over time. Alterations to ocular behaviour suggest that eye tracking may assist in determining cannabis-related driver impairment or intoxication. Australian and New Zealand Clinician Trials Registry, https://anzctr.org.au(ACTRN12619000932167) .

项与 CannEpil 相关的新闻（医药）

2023-05-31

·PRNewswire

Historic Milestone: UK Patients Receive First CannEpil® Delivery through 'I AM Billy Foundation' and GMC Specialist Register

MGC Pharma's pioneering cannabis-based treatment for refractory epilepsy now available to patients in the United Kingdom LONDON, May 31, 2023 /PRNewswire/ -- MGC Pharmaceuticals Ltd. (LSE: MXC), (ASX: MXC), (OTC: MGCLF), a leading European pharmaceutical firm specializing in plant-derived medications, announced today that its ground-breaking Investigational Medicinal Product (IMP), CannEpil®, has been successfully imported and received by its first patients in the United Kingdom. CannEpil® is a high-CBD, low-THC formulation, delivered via an oral mucosal solution. It is part of MGC's rigorous clinical development programme for patients suffering from refractory epilepsy, also known as drug-resistant epilepsy. Following a safety study in Australia, which confirmed CannEpil® was safe for post-treatment driving activities, CannEpil® was distributed and prescribed in Ireland under full governmental health insurance coverage in 2019. The first patient to receive CannEpil® in the UK was supported by the 'I AM Billy Foundation', an initiative led by Charlotte Caldwell, whose son Billy was the first person to receive an NHS prescription for medical cannabis in 2018. Approximately 25,000 people in the UK are currently treated with medical cannabis for conditions such as chronic pain, epilepsy, and Parkinson's disease. Besides, MGC Pharma has delivered CannEpil® to its first patient in the UK via the Named Patient Request programme, following the announcement on 11th April 2023. The initiative permits clinicians listed on The General Medical Council (GMC) specialist register to prescribe CannEpil®. The delivery also supports the RESCAS study, a research initiative aiming to address the substantial unmet medical need of refractory epilepsy. MGC Pharma's proprietary ZAM app, announced on 15th March 2023, will record patients' daily metrics, symptoms, and treatment impact, providing a detailed record of the study and a deeper understanding of CannEpil® effects on refractory epilepsy patients. CannEpil® was supplied to the 'I AM Billy Foundation' through the NHS's Refractory Epilepsy Specialist Clinical Advisory Service, the only route in the UK for patients to receive public funding for cannabis-based treatments of refractory epilepsy. Roby Zomer, Managing Director and CEO of MGC Pharma, said: "Fulfilling the first UK patient's CannEpil® treatment signifies MGC Pharma's commitment to improving access to effective epilepsy treatment. We're proud to collaborate with the 'I AM Billy Foundation' on this significant endeavor. We aim to ensure patient access to high-quality, cannabis-based medicinal products. With the first CannEpil® prescription via Named Patient Request, we're making substantial progress towards increasing access to effective refractory epilepsy treatment in the UK and Ireland, with other key territories to soon follow." Logo: SOURCE MGC Pharmaceuticals Ltd

上市批准

2023-04-11

·PRNewswire

MGC Pharma's CannEpil® Now Accessible to UK Patients on Named Patient Request Basis

European pharmaceutical company offers its investigational medicinal product to a wide range of specialist medical practitioners in the United Kingdom Epidiolex's Success Highlights Potential for MGC Pharma's CannEpil® The recent success of Epidiolex, a CBD-based epilepsy treatment that generated $296 million in sales in 2019, highlights the potential for MGC Pharma's CannEpil® in the UK market. This underlines the potential of CannEpil®, an investigational medicinal product for patients suffering from refractory epilepsy, to make a significant impact in the UK market. LONDON, April 11, 2023 /PRNewswire/ -- MGC Pharmaceuticals Ltd. (LSE: MXC), (ASX: MXC), (OTC: MGCLF), a European based pharmaceutical company specializing in the development and supply of affordable, ethically produced plant-inspired medicines, announces that its proprietary product CannEpil® is now available to patients in the UK by Named Patient Request. MGC Pharma's CannEpil® is an investigational medicinal product (IMP) designed for patients suffering from refractory epilepsy, also known as drug-resistant epilepsy. The high-CBD, low-THC formulation is administered via an oral mucosal solution and is currently undergoing a clinical development program. The availability of CannEpil® in the UK follows the company's announcement that it is providing the product for an observational trial supported by the I am Billy Foundation. With this development, clinicians in the UK listed on the General Medical Council (GMC) Specialist Register can now prescribe CannEpil®. This is a significant milestone for MGC Pharma and patients with unmet medical needs, as it expands the company's reach within the healthcare and life science sectors as an innovative plant-inspired pharmaceutical company. CannEpil® has already been prescribed to hundreds of patients across Australia and the Republic of Ireland over the past three years. In 2019, it became the first product to be available with coverage in the Republic of Ireland under the Long Term Illness and General Medical Services schemes. The data collected from patients using CannEpil® will be used to further evaluate the safety and efficacy of the drug, supporting future submissions for marketing authorization. Epilepsy affects approximately 50 million people worldwide, with 33% of adults and 20-25% of children suffering from refractory epilepsy. CBD has been proven effective in reducing seizure frequency and severity, as supported by open-label studies, observational studies, randomized clinical trials (RCTs), and large-scale systematic reviews. Roby Zomer, Managing Director and CEO of MGC Pharmaceuticals, commented: "The availability of CannEpil® by Named Patient Request marks a momentous breakthrough for MGC Pharma. The product will now be available to a wide cohort of specialist medical practitioners in the UK, which is testament to the progress we are making." "We are extremely proud of the progress we have achieved thus far, and we are pleased that CannEpil® has been selected as a treatment within an observational patient trial in association with the I am Billy Foundation. We look forward to updating the market on the results of this trial in due course." Twitter: @MGC_Pharma Facebook: @mgcpharmaceuticals Logo - SOURCE MGC Pharmaceuticals Ltd.

上市批准临床研究

100 项与 CannEpil 相关的药物交易

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