Spasticity following stroke MedDRA version: 20.0 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852
Conditions
Interventions
Trade Name: SATIVEX - SPRAY PER MUCOSA ORALE 3 FLACONI NEBULIZZATORI CON POMPA DOSATRICE DA 10 ML - 90 EROGAZIONI
Product Name: Sativex oromucosal spray
Pharmaceutical Form: Oromucosal spray
Pharmaceu
Sponsors
IRCCS-A.O.U. SAN MARTINO-IST
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Daily spasms count 2) Bladder dysfunction (0-10 numeric rating scale) 3) Subjective amount of pain (O-10 numeric rating scale) 4) Number of Patients with adverse events and seriouse adverse events 5) Number of treatments interruptions related to adverse events 6) Systolic/ dyastolic blood pressure and heart rate 7) Modified Ashworth spasticity scale score;Timepoint(s) of evaluation of this end point: 1) 12 weeks 2) 12 weeks 3) 12 weeks 4) 12 weeks 5) 12 weeks 6) 12 weeks 7) 12 weeks | — |
Countries
Italy
Contacts
Public ContactUO Clinical Trials
IRCCS AOU San Martino-IST
Outcome results
None listed