europhysiological assessment of the effect of Sativex to treat spasticity following stroke

Phase 1

• Conditions: Spasticity following stroke; MedDRA version: 20.0Level: LLTClassification code 10041416Term: SpasticitySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-001034-10-IT
• Lead Sponsor: IRCCS-A.O.U. SAN MARTINO-IST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-21
• Study Completion: 2020-02-20
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess if Sativex is able to reduce spasticity in chronic stroke patients;Secondary Objective: To evaluate the tolerability of Sativex;Primary end point(s): To assess the effect of the tested treatment on muscle spasticity assessed with the stretch reflex and the 0-10 numeric rating scale for spasticity (NRS) ;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Daily spasms count<br>2) Bladder dysfunction (0-10 numeric rating scale)<br>3) Subjective amount of pain (O-10 numeric rating scale)<br>4) Number of Patients with adverse events and seriouse adverse events<br>5) Number of treatments interruptions related to adverse events<br>6) Systolic/ dyastolic blood pressure and heart rate<br>7) Modified Ashworth spasticity scale score;Timepoint(s) of evaluation of this end point: 1) 12 weeks<br>2) 12 weeks<br>3) 12 weeks<br>4) 12 weeks<br>5) 12 weeks<br>6) 12 weeks<br>7) 12 weeks