europhysiological assessment of the effect of Sativex (THC/CBD oromucosal spray) as add-on to treat spasticity following stroke - SativexStroke

IRCCS-A.O.U. SAN MARTINO-IST0 个研究点目标入组 41 人开始时间: 2018年9月21日最近更新: 2022年4月4日

试验速览

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•patients of either sex, at least 18 years of age, with a history of stroke (hemorrhagic or ischemic) occurred at least 3 months earlier and presence of spasticity rated between 1 and 3 at the Ashworth Modified Scale (MAS) in at least one of the following segments: flexor muscles of the wrist, flexor muscles of the forearm, extensor muscles of the leg, foot plantiflexors.
•Current antispastic therapy has to be stable since at least three months before inclusion into the study and will be maintained stable across the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•treatment with botulinum toxin injection for the relief of spasticity within 4 months prior to the screening visit, CHA2DS2VASc score (Melgaard, 2015) higher than 6, presence of a cardiovascular risk at cardiological visit, pregnant or lactating women, or any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or the patient’s ability to participate in the study.

发起方

IRCCS-A.O.U. SAN MARTINO-IST