AUTHOR=Marinelli Lucio , Puce Luca , Mori Laura , Leandri Massimo , Rosa Gian Marco , Currà Antonio , Fattapposta Francesco , Trompetto Carlo 

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

JOURNAL=Frontiers in Neurology

VOLUME=Volume 13 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.892165

DOI=10.3389/fneur.2022.892165

ISSN=1664-2295

ABSTRACT=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 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 one 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. Lack of nabiximols effect could be related to low pain levels in recruited patients or to different spasticity mechanisms between post-stroke and multiple sclerosis patients.