Study register · detailProspektive, multizentrische, offene, nichtinterventionelle Studie (Real-World) · Spasticity · 2024
Patient-reported benefits from nabiximols treatment in multiple sclerosis-related spasticity exceed conventional measures.
Haupts et al.·Neurodegenerative Disease ManagementImpact 1.5
Clear benefitGRADEVery low6 citations
Samplen = 51 Pat.
Duration12 weeks
EndpointGoal Attainment Scale
Blindingn.a.
DesignProspektive, multizentrische, offene, nichtinterventionelle Studie (Real-World)
Cannabinoidkombination
THC:CBD1:1
Routeoromukosal
”Key finding
Nabiximols showed clinically meaningful improvements in MS-related spasticity with a 46% increase in Goal Attainment Scale, 23% improvement in walking speed, and clinically relevant improvements in spasticity, pain, sleep quality and bladder dysfunction.
Summary
n=51 MS patients with spasticity (49 responders), add-on nabiximols (Sativex) oromucosal spray, 12 weeks prospective multicenter real-world setting (Germany). Primary endpoint Goal Attainment Scale (GAS) increased by 46% (35,2 → 51,4; p<0,001). Walking speed improved by 23% after 4 and 12 weeks. Clinically meaningful improvements in NRS scores for spasticity, pain, sleep quality and bladder function.
P
PopulationAdults with MS-related spasticity, n=51 (of which 49 nabiximols responders)
I
InterventionNabiximols oromucosal spray (Sativex) as add-on, 12 weeks, real-world
O
OutcomeGoal Attainment Scale score increased by 46% from baseline to week 12 (35,2 vs. 51,4; p<0,001); also improvement in walking speed of 23% as well as clinically relevant NRS improvements for spasticity, pain, sleep quality and bladder dysfunction
Confidence in the evidence
Very lowLowModerateHigh
Very low
The lowest GRADE level, the effect estimate remains uncertain.
Design: Prospektive, multizentrische, offene, nichtinterventionelle Studie (Real-World)
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Abstract
This prospective, multicenter, open-label, noninterventional 12-week study investigated the effectiveness and tolerability of add-on nabiximols oromucosal spray (Sativex) in the real-world setting in Germany. The main analysis set comprised 51 adult patients (49 nabiximols responders) with multiple sclerosis (MS) spasticity. The mean overall goal attainment scale score (primary outcome measure) increased by 46% from baseline to week 12 (35.2 vs 51.4; p<0.001). Mean gait speed was improved by 23% at 4 and 12 weeks. Clinically meaningful improvements in mean 0-10 numerical rating scale scores for spasticity, pain, sleep quality and urinary bladder dysfunction were recorded at 4 and 12 weeks. Nabiximols is a useful therapeutic option for patients with MS spasticity.