Cannabidiol in conjunction with clobazam: analysis of four randomized controlled trials.

Adult Anticonvulsants / administration & dosage Cannabidiol / administration & dosage Clobazam / administration & dosage Epilepsies, Myoclonic / drug therapy Female Humans Lennox Gastaut Syndrome / drug therapy Male Randomized Controlled Trials as Topic
cannabidiol clobazam epilepsies epilepsy lennox-gastaut syndrome myoclonic seizures

Journal

Acta neurologica Scandinavica
ISSN: 1600-0404
Titre abrégé: Acta Neurol Scand
Pays: Denmark
ID NLM: 0370336

Informations de publication

Date de publication:
Feb 2021
Historique:
received: 07 07 2020
revised: 03 09 2020
accepted: 14 09 2020
pubmed: 25 9 2020
medline: 20 1 2021
entrez: 24 9 2020
Statut: ppublish

Résumé

To assess the efficacy and safety profile of add-on cannabidiol (CBD) in patients with Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) on clobazam and in the overall population of four randomized, controlled phase 3 trials. Patients received plant-derived, highly purified CBD medicine (Epidiolex 396 patients with LGS (49% on clobazam) and 318 patients with DS (64% on clobazam) were included. CBD treatment resulted in a reduction in primary seizure frequency vs placebo in the overall population (treatment ratio [95% confidence interval]: LGS, 0.70 [0.62-0.80]; DS, 0.71 [0.60-0.83]) and in patients receiving clobazam (LGS, 0.56 [0.47-0.67]; DS, 0.63 [0.52-0.77]). The antiseizure efficacy of CBD was also demonstrated across other endpoints vs placebo (≥50% responder rate, total seizure frequency, number of seizure-free days, and Subject/Caregiver Global Impression of Change scores) in the overall populations and in patients receiving clobazam. There were higher incidences of somnolence and sedation in patients on CBD and clobazam. Most incidences of elevated transaminases occurred in patients on concomitant valproate and, to a lesser extent, clobazam. Add-on CBD was effective in reducing seizures in the overall populations and in conjunction with clobazam. Somnolence and sedation occurred more frequently in patients on CBD and clobazam.

Identifiants

DOI: 10.1111/ane.13351 PMID: 32969022 PMC: PMC7821324
pubmed: 32969022
doi: 10.1111/ane.13351
pmc: PMC7821324
doi:

Substances chimiques

Anticonvulsants 0
Cannabidiol 19GBJ60SN5
Clobazam 2MRO291B4U

Types de publication

Journal Article Meta-Analysis

Langues

eng

Sous-ensembles de citation

IM

Pagination

154-163

Subventions

Organisme : GW Research Ltd

Informations de copyright

© 2020 The Authors. Acta Neurologica Scandinavica published by John Wiley & Sons Ltd.

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Auteurs

Boudewijn Gunning (B)

Stichting Epilepsie Instellingen Nederland, Zwolle, The Netherlands.
ORCID: 0000-0003-1885-1113

Maria Mazurkiewicz-Bełdzińska (M)

Medical University of Gdańsk, Gdańsk, Poland.
ORCID: 0000-0002-9405-5066

Richard F M Chin (RFM)

Royal Hospital for Sick Children, Edinburgh, UK.

Hari Bhathal (H)

Centro Médico Teknon, Neurocenter Barcelona, Barcelona, Spain.

Charlotte Nortvedt (C)

GW Research Ltd, Cambridge, UK.

Eduardo Dunayevich (E)

Greenwich Biosciences, Inc, Carlsbad, CA, USA.

Daniel Checketts (D)

GW Research Ltd, Cambridge, UK.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Cannabidiol in conjunction with clobazam:...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Agents du système nerveux central › Anticonvulsivants › Cannabidiol in conjunction with clobazam:...
questionsmedicales.fr › Composés chimiques organiques › Hydrocarbures › Terpènes › Cannabinoïdes › Cannabidiol › Cannabidiol in conjunction with clobazam:...
questionsmedicales.fr › Composés hétérocycliques › Composés hétérocycliques à cycles fusionnés › Composés hétérobicycliques › Benzazépines › Benzodiazépines › Clobazam › Cannabidiol in conjunction with clobazam:...
questionsmedicales.fr › Maladies du système nerveux › Maladies du système nerveux central › Encéphalopathies › Épilepsie › Syndromes épileptiques › Épilepsies myocloniques › Cannabidiol in conjunction with clobazam:...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Cannabidiol in conjunction with clobazam:...
questionsmedicales.fr › Malformations et maladies congénitales, héréditaires et néonatales › Maladies génétiques congénitales › Syndrome de Lennox-Gastaut › Cannabidiol in conjunction with clobazam:...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › Cannabidiol in conjunction with clobazam:...