GW Pharmaceuticals Ltd. [provisional name] (Sativex® for multiple sclerosis [provisional name])
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A Study to Evaluate the Efficacy of Sativex in Relieving Symptoms of Spasticity Due to Multiple Sclerosis

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Registry of Trials clinicaltrials.gov
Year 2005
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This article is included in 3 Systematic reviews Systematic reviews (3 references) 1 Broad synthesis Broad syntheses (1 reference)

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The purpose of this study was to assess the efficacy of Sativex in relieving symptoms of spasticity in multiple sclerosis

Primary study

Unclassified

A randomised controlled study of Sativex® in patients with symptoms of spasticity due to multiple sclerosis

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Conference 22nd Congress of the ECTRIMS
Year 2006

This article is included in 2 Systematic reviews Systematic reviews (2 references) 1 Broad synthesis Broad syntheses (1 reference)

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Primary study

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A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis

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Journal Neurological research
Year 2010
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This article is included in 30 Systematic reviews Systematic reviews (30 references) 1 Broad synthesis Broad syntheses (1 reference)

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Background: Muscle spasticity is common in multiple sclerosis (MS), occurring in more than 60% of patients. Objective: To compare Sativex with placebo in relieving symptoms of spasticity due to MS. Methods: A 15-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group study in 337 subjects with MS spasticity not fully relieved with current anti-spasticity therapy. Results: The primary endpoint was a spasticity 0-10 numeric rating scale (NRS). Intention-to-treat (ITT) analysis showed a non-significant improvement in NRS score, in favor of Sativex. The per protocol (PP) population (79% of subjects) change in NRS score and responder analyses (≥30% improvement from baseline) were both significantly superior for Sativex, compared with placebo: -1·3 versus -0·8 points (change from baseline, p=0·035); and 36% versus 24% (responders, p=0·040). These were supported by the time to response (ITT: p=0·068; PP: p=0·025) analyses, carer global impression of change assessment (p=0·013) and timed 10-meter walk (p=0·042). Among the subjects who achieved a ≥30% response in spasticity with Sativex, 98, 94 and 73% reported improvements of 10, 20 and 30%, respectively, at least once during the first 4 weeks of treatment. Sativex was generally well tolerated, with most adverse events reported being mild-to-moderate in severity. Discussion and conclusions: The 0-10 NRS and responder PP analyses demonstrated that Sativex treatment resulted in a significant reduction in treatment-resistant spasticity, in subjects with advanced MS and severe spasticity. The response observed within the first 4 weeks of treatment appears to be a useful aid to prediction of responder/non-responder status. © 2010 Maney Publishing.