Newest evidence for tetrahydrocannabinol: cannabidiol oromucosal spray from randomized clinical trials
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064190%3A_____%2F19%3AN0000068" target="_blank" >RIV/00064190:_____/19:N0000068 - isvavai.cz</a>
Nalezeny alternativní kódy
RIV/00216208:11120/19:43917584
Výsledek na webu
<a href="http://dx.doi.org/10.2217/nmt-2018-0050" target="_blank" >http://dx.doi.org/10.2217/nmt-2018-0050</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.2217/nmt-2018-0050" target="_blank" >10.2217/nmt-2018-0050</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Newest evidence for tetrahydrocannabinol: cannabidiol oromucosal spray from randomized clinical trials
Popis výsledku v původním jazyce
Subsequent to EMA approval of tetrahydrocannabinol (THC): cannabidiol (CBD) oromucosal spray based on results of various studies, including an enriched-design clinical trial, two newer postapproval randomized trials have confirmed its efficacy and safety for treating resistant multiple sclerosis spasticity, while simultaneously addressing specific authoritie's concerns. A double-blind, placebo-controlled, Phase IV trial, conducted as part of the EMA's risk management plan, found no effect of THC:CBD spray on cognition and mood after 50 weeks of treatment. In the Sativex (R) as add-on therapy versus further optimized first-line ANTispastics (SAVANT) study, add-on THC:CBD spray was significantly more effective than readjusting standard antispasticity therapy and provided new evidence of efficacy as requested by German authorities. SAVANT results support practical recommendations for treating resistant multiple sclerosis spasticity in daily practice.
Název v anglickém jazyce
Newest evidence for tetrahydrocannabinol: cannabidiol oromucosal spray from randomized clinical trials
Popis výsledku anglicky
Subsequent to EMA approval of tetrahydrocannabinol (THC): cannabidiol (CBD) oromucosal spray based on results of various studies, including an enriched-design clinical trial, two newer postapproval randomized trials have confirmed its efficacy and safety for treating resistant multiple sclerosis spasticity, while simultaneously addressing specific authoritie's concerns. A double-blind, placebo-controlled, Phase IV trial, conducted as part of the EMA's risk management plan, found no effect of THC:CBD spray on cognition and mood after 50 weeks of treatment. In the Sativex (R) as add-on therapy versus further optimized first-line ANTispastics (SAVANT) study, add-on THC:CBD spray was significantly more effective than readjusting standard antispasticity therapy and provided new evidence of efficacy as requested by German authorities. SAVANT results support practical recommendations for treating resistant multiple sclerosis spasticity in daily practice.
Klasifikace
Druh
J<sub>imp</sub> - Článek v periodiku v databázi Web of Science
CEP obor
—
OECD FORD obor
30103 - Neurosciences (including psychophysiology)
Návaznosti výsledku
Projekt
—
Návaznosti
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Ostatní
Rok uplatnění
2019
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
NEURODEGENERATIVE DISEASE MANAGEMENT
ISSN
1758-2024
e-ISSN
1758-2032
Svazek periodika
9
Číslo periodika v rámci svazku
5, Supplement: S
Stát vydavatele periodika
GB - Spojené království Velké Británie a Severního Irska
Počet stran výsledku
5
Strana od-do
9-13
Kód UT WoS článku
000458334300003
EID výsledku v databázi Scopus
2-s2.0-85060921291