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Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study

BACKGROUND: Nabiximols is a cannabis-based drug to treat spasticity-associated symptoms currently approved for patients with multiple sclerosis only. Cannabinoids are useful in an increasing number of medical conditions but may bear an increased risk for cardiovascular events. SativexStroke is a dou...

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Autores principales: Marinelli, Lucio, Puce, Luca, Mori, Laura, Leandri, Massimo, Rosa, Gian Marco, Currà, Antonio, Fattapposta, Francesco, Trompetto, Carlo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9261779/
https://www.ncbi.nlm.nih.gov/pubmed/35812088
http://dx.doi.org/10.3389/fneur.2022.892165
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author Marinelli, Lucio
Puce, Luca
Mori, Laura
Leandri, Massimo
Rosa, Gian Marco
Currà, Antonio
Fattapposta, Francesco
Trompetto, Carlo
author_facet Marinelli, Lucio
Puce, Luca
Mori, Laura
Leandri, Massimo
Rosa, Gian Marco
Currà, Antonio
Fattapposta, Francesco
Trompetto, Carlo
author_sort Marinelli, Lucio
collection PubMed
description BACKGROUND: Nabiximols is a cannabis-based drug to treat spasticity-associated symptoms currently approved for patients with multiple sclerosis only. Cannabinoids are useful in an increasing number of medical conditions but may bear an increased risk for cardiovascular events. SativexStroke is a double-blind randomized placebo-controlled crossover monocentric clinical trial investigating the efficacy and safety of nabiximols in patients with spasticity following stroke. METHODS: Patients were treated with nabiximols oromucosal spray or placebo and assessed before and after two phases of 1-month duration each. Cardiovascular safety was assessed before and during the trial. Primary endpoints were changes in spasticity numeric rating scale scores and electromyographic recording of the stretch reflex in affected wrist flexors. Secondary outcome measures were numeric rating scale scores for pain, sleep and bladder function, the number of daily spasms and clinical assessment of spasticity with the modified Ashworth scale. The study was registered with the EudraCT number 2016-001034-10. RESULTS: Between May 2, 2018, and February 20, 2020, 41 patients entered the study. Seven patients did not complete the study, so 34 were included in the analysis. Two serious adverse events occurred, but none related to cardiovascular function. Primary and secondary efficacy outcome measures did not change from baseline during nabiximols treatment relative to placebo. CONCLUSION: This study suggests that nabiximols use is probably safe in stroke patients, therefore cannabinoid usefulness may be further investigated. The lack of nabiximols effect could be related to low pain levels in recruited patients or different spasticity mechanisms between post-stroke and multiple sclerosis patients. Similarly, a beneficial effect of nabiximols could have emerged if more patients with a higher level of spasticity at baseline were recruited. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001034-10/IT.
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spelling pubmed-92617792022-07-08 Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study Marinelli, Lucio Puce, Luca Mori, Laura Leandri, Massimo Rosa, Gian Marco Currà, Antonio Fattapposta, Francesco Trompetto, Carlo Front Neurol Neurology BACKGROUND: Nabiximols is a cannabis-based drug to treat spasticity-associated symptoms currently approved for patients with multiple sclerosis only. Cannabinoids are useful in an increasing number of medical conditions but may bear an increased risk for cardiovascular events. SativexStroke is a double-blind randomized placebo-controlled crossover monocentric clinical trial investigating the efficacy and safety of nabiximols in patients with spasticity following stroke. METHODS: Patients were treated with nabiximols oromucosal spray or placebo and assessed before and after two phases of 1-month duration each. Cardiovascular safety was assessed before and during the trial. Primary endpoints were changes in spasticity numeric rating scale scores and electromyographic recording of the stretch reflex in affected wrist flexors. Secondary outcome measures were numeric rating scale scores for pain, sleep and bladder function, the number of daily spasms and clinical assessment of spasticity with the modified Ashworth scale. The study was registered with the EudraCT number 2016-001034-10. RESULTS: Between May 2, 2018, and February 20, 2020, 41 patients entered the study. Seven patients did not complete the study, so 34 were included in the analysis. Two serious adverse events occurred, but none related to cardiovascular function. Primary and secondary efficacy outcome measures did not change from baseline during nabiximols treatment relative to placebo. CONCLUSION: This study suggests that nabiximols use is probably safe in stroke patients, therefore cannabinoid usefulness may be further investigated. The lack of nabiximols effect could be related to low pain levels in recruited patients or different spasticity mechanisms between post-stroke and multiple sclerosis patients. Similarly, a beneficial effect of nabiximols could have emerged if more patients with a higher level of spasticity at baseline were recruited. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001034-10/IT. Frontiers Media S.A. 2022-06-23 /pmc/articles/PMC9261779/ /pubmed/35812088 http://dx.doi.org/10.3389/fneur.2022.892165 Text en Copyright © 2022 Marinelli, Puce, Mori, Leandri, Rosa, Currà, Fattapposta and Trompetto. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
Marinelli, Lucio
Puce, Luca
Mori, Laura
Leandri, Massimo
Rosa, Gian Marco
Currà, Antonio
Fattapposta, Francesco
Trompetto, Carlo
Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study
title Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study
title_full Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study
title_fullStr Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study
title_full_unstemmed Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study
title_short Cannabinoid Effect and Safety in Spasticity Following Stroke: A Double-Blind Randomized Placebo-Controlled Study
title_sort cannabinoid effect and safety in spasticity following stroke: a double-blind randomized placebo-controlled study
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9261779/
https://www.ncbi.nlm.nih.gov/pubmed/35812088
http://dx.doi.org/10.3389/fneur.2022.892165
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