The protocol for the Cannabidiol in children with refractory epileptic encephalopathy (CARE-E) study: a phase 1 dosage escalation study
| Autor: | Edward Leung, Darrell D. Mousseau, Richard J. Huntsman, Lionel Carmant, Jane Alcorn, Blair Seifert, Richard Tang-Wai, Scott Corley, Linda Huh, Andrew W. Lyon, Darren Reithmeier, Hyun J. Lim, Erin J. Prosser-Loose, Jose F. Tellez-Zenteno, Bryan V. Acton |
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| Přispěvatelé: | University of Manitoba |
| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_specialty
Drug Resistant Epilepsy medicine.medical_treatment Limited access 03 medical and health sciences Study Protocol 0302 clinical medicine Pharmacokinetics Internal medicine medicine Cannabidiol Humans 030212 general & internal medicine Adverse effect Child Cannabis biology Seizure types business.industry Plant Extracts Epileptic encephalopathy lcsh:RJ1-570 Infant lcsh:Pediatrics biology.organism_classification Anticonvulsant Child Preschool Pediatrics Perinatology and Child Health Quality of Life Anticonvulsants Drug Therapy Combination CanniMed® business Pediatric epilepsy 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | BMC Pediatrics BMC Pediatrics, Vol 18, Iss 1, Pp 1-9 (2018) |
| DOI: | 10.1186/s12887-018-1191-y |
| Popis: | Background: Initial studies suggest pharmaceutical grade cannabidiol (CBD) can reduce the frequency of convulsive seizures and lead to improvements in quality of life in children affected by epileptic encephalopathies. With limited access to pharmaceutical CBD, Cannabis extracts in oil are becoming increasingly available. Physicians show reluctance to recommend Cannabis extracts given the lack of high quality safety data especially regarding the potential for harm caused by other cannabinoids, such as Δ9-tetrahydrocannabinol (Δ9-THC). The primary aims of the study presented in this protocol are (i) To determine whether CBD enriched Cannabis extract is safe and well-tolerated for pediatric patients with refractory epilepsy, (ii) To monitor the effects of CBD-enriched Cannabis extract on the frequency and duration of seizure types and on quality of life. Methods: Twenty-eight children with treatment resistant epileptic encephalopathy ranging in age from 1 to 10 years will be recruited in four Canadian cities into an open-label, dose-escalation phase 1 trial. The primary objectives for the study are (i) To determine if the CBD-enriched Cannabis herbal extract is safe and well-tolerated for pediatric patients with treatment resistant epileptic encephalopathy and (ii) To determine the effect of CBD-enriched Cannabis herbal extract on the frequency and duration of seizures. Secondary objectives include (i) To determine if CBD-enriched Cannabis herbal extracts alter steady-state levels of co-administered anticonvulsant medications. (ii) To assess the relation between dose escalation and quality of life measures, (iii) To determine the relation between dose escalation and steady state trough levels of bioactive cannabinoids. (iv) To determine the relation between dose escalation and incidence of adverse effects. Discussion: This paper describes the study design of a phase 1 trial of CBD-enriched Cannabis herbal extract in children with treatment-resistant epileptic encephalopathy. This study will provide the first high quality analysis of safety of CBD-enriched Cannabis herbal extract in pediatric patients in relation to dosage and pharmacokinetics of the active cannabinoids. Trial registration http://clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2016 Dec 16. Identifier NCT03024827, Cannabidiol in Children with Refractory Epileptic Encephalopathy: CARE-E; 2017 Jan 19 [cited 2017 Oct]; Available from: http://clinicaltrials.gov/ct2/show/NCT03024827 |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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