CannEpil (cannabis oil) / Argent BioPharma - LARVOL DELTA

Argent soars as cannabinoid-based epilepsy drug gains approval in Germany (Stockhead) - "Under the special access scheme (SAS), Argent’s proprietary therapy CannEpil is now available for prescription by qualified physicians in Germany. Patients may be eligible for health insurance coverage depending on their physician’s recommendation and case assessment."

EMA approval • Reimbursement • Epilepsy

Study of Safety and Efficacy of MGCND00EP1 as an Add on Treatment in Children and Adolescents With Resistant Epilepsies (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: MGC Pharmaceuticals d.o.o | N=103 ➔ 0 | Trial completion date: Sep 2024 ➔ May 2024 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial completion date • Trial withdrawal • CNS Disorders • Epilepsy

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. (PubMed, Eur Neuropsychopharmacol) - "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)."

Journal • Anesthesia • Cognitive Disorders

Effect of CannEpil on simulated driving performance and co-monitoring of ocular activity: A randomised controlled trial. (PubMed, J Psychopharmacol) - "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)."

Journal

Study of Safety and Efficacy of MGCND00EP1 as an Add on Treatment in Children and Adolescents With Resistant Epilepsies (clinicaltrials.gov) - P2 | N=103 | Not yet recruiting | Sponsor: MGC Pharmaceuticals d.o.o | Trial completion date: Jun 2023 ➔ Sep 2024 | Trial primary completion date: Jun 2023 ➔ Aug 2024

Trial completion date • Trial primary completion date • CNS Disorders • Epilepsy • CORIN

MGC Pharmaceuticals Enters Partnership with Sciensus Rare for Distribution of Cannabinoids to Treat Refractory Epilepsy, Dementia and Alzheimer’s in the EU and UK (PRNewswire) - "MGC Pharmaceuticals Ltd...has signed an exclusive distribution agreement with Sciensus Rare, a part of UK health care group, Sciensus, for the distribution of CannEpil® and CogniCann® in key European territories and the UK. The agreement is for the distribution in key European territories and the UK for CannEpil®, used to treat Drug Resistant Epilepsy, and CogniCann®, used to treat patients with Dementia and Alzheimer's disease."

Licensing / partnership • Alzheimer's Disease • CNS Disorders • Epilepsy

Study of Safety and Efficacy of MGCND00EP1 as an Add on Treatment in Children and Adolescents With Resistant Epilepsies (clinicaltrials.gov) - P2 | N=103 | Not yet recruiting | Sponsor: MGC Pharmaceuticals d.o.o | Trial completion date: Dec 2022 ➔ Jun 2023 | Trial primary completion date: Apr 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • CNS Disorders • Epilepsy

MHRA grants import approval for cannabinoid Epilepsy treatment (EPM Magazine) - "The import approval was given to MGC Pharma’s CannEpil+ product – a biosimilar to its CannEpil phytocannabinoid treatment for Refractory (or drug-resistant) Epilepsy...The decision by the MHRA means that doctors UK in can now issue a prescription for CannEpil+ for both adults and children. CannEpil+ will initially be used to treat 10 patients in the UK who suffer from Refractory Epilepsy."

European regulatory • CNS Disorders • Epilepsy

Study of Safety and Efficacy of MGCND00EP1 as an Add on Treatment in Children and Adolescents With Resistant Epilepsies (clinicaltrials.gov) - P2; N=103; Not yet recruiting; Sponsor: MGC Pharmaceuticals d.o.o; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Dec 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Epilepsy

New Cannabis Studies Suggest Help with Pain and Sleep in Fibromyalgia - "Daniel Clauw - a pretty conservative researcher - who is down on opioid use - has said he would love to see clinical trials on Cannabis in fibromyalgia but that the conditions in the U.S. make it difficult."

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Cannabis Oil How Many Pieces [Google translation] - "Elaine Husni...explains the effects of barometric pressure and why it could be said to be related to pain."

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