Pharmacological management of spasticity in multiple sclerosis: Systematic review and consensus paper

Otero‐Romero, Susana; Sastre‐Garriga, Jaume; Comi, Giancarlo; Hartung, Hans Peter; Sørensen, Per Soelberg; Thompson, Alan J.; Vermersch, Patrick; Gold, Ralf; Montalbán, Xavier

doi:10.1177/1352458516643600

Cited by 135 publications

(85 citation statements)

References 86 publications

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“…Sativex ® is a new, add-on treatment option for patients with moderate to severe MSS and it is administered as a spray containing the active substances delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) at a ratio of 1: 1. The findings from clinical studies have shown that THC:CBD oromucosal spray reduces spasticity in MS patients and is well-tolerated [10][11][12] , and it is recommended as a second-or third-line option in the most recent ECTRIMS endorsed MSS management guidance paper [13] . This prospective, multicentre, non-interventional observational study was performed to collect real-life data on the effectiveness and tolerability of THC:CBD oromucosal spray in everyday clinical practice.…”

Section: Introductionmentioning

confidence: 99%

Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice

Vermersch

Trojano

2016

Eur Neurol

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Background: Tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (Sativex®) is an add-on therapy for moderate-to-severe multiple sclerosis (MS)-related drug-resistant spasticity (MSS). Aim: The MOVE-2 EU study collected data from everyday clinical practice concerning the effectiveness and tolerability of THC:CBD. Methods: This was an observational, prospective, multicentre, non-interventional study. Patients with resistant MSS prescribed add-on THC:CBD oromucosal spray according to approved labelling, were followed for 3 months. After 1 month, only responders (≥20% improvement in spasticity) continued treatment. The main endpoints were the evolution of MSS and associated symptoms, quality of life (QoL) and tolerability. Results: Four hundred and thirty three patients (55% female) were recruited (98% in Italy). The mean duration of MSS was 7.4 years and baclofen was used by 78.1% of participants. Three hundred and forty nine participants continued with THC:CBD oromucosal spray after 1 month, and 281 after 3 months. THC:CBD mean dosage was 6 sprays/day. MSS scores and spasticity-related symptoms (spasms, fatigue, pain, sleep quality and bladder dysfunction) were significantly improved by THC:CBD at 3 months, as were activities of daily living, and QoL (EQ-5D VAS). Adverse events, none of which were severe or serious, were reported by 10.4% of patients. Conclusions: In everyday clinical practice, THC:CBD oromucosal spray provided symptomatic relief of MSS and related troublesome symptoms.

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Section: Introductionmentioning

confidence: 99%

Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice

Vermersch

Trojano

2016

Eur Neurol

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“…There is a reduction in motor dysfunction and pain, observed in meta-analysis of several clinical studies. However, an increased incidence of non-serious side effects was also reported (Wade et al, 2010; Otero-Romero et al, 2016). Importantly, a review by the National Institute for Health and Care Excellence in the United Kingdom, recommended against the use of Sativex® to treat spasticity in people with MS because it is not a cost effective treatment (Multiple sclerosis in adults: management | 1-recommendations | Guidance and guidelines | NICE, 2014).…”

Section: Multiple Sclerosismentioning

confidence: 89%

“…Importantly, a review by the National Institute for Health and Care Excellence in the United Kingdom, recommended against the use of Sativex® to treat spasticity in people with MS because it is not a cost effective treatment (Multiple sclerosis in adults: management | 1-recommendations | Guidance and guidelines | NICE, 2014). For a recent and comprehensive analysis of clinical studies see the work of Otero-Romero et al (2016). …”

Section: Multiple Sclerosismentioning

confidence: 99%

Cannabinoid Receptors in the Central Nervous System: Their Signaling and Roles in Disease

Kendall

Yudowski

2017

Front. Cell. Neurosci.

250

208

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The identification and cloning of the two major cannabinoid (CB1 and CB2) receptors together with the discovery of their endogenous ligands in the late 80s and early 90s, resulted in a major effort aimed at understanding the mechanisms and physiological roles of the endocannabinoid system (ECS). Due to its expression and localization in the central nervous system (CNS), the CB1 receptor together with its endogenous ligands (endocannabinoids (eCB)) and the enzymes involved in their synthesis and degradation, has been implicated in multiple pathophysiological events ranging from memory deficits to neurodegenerative disorders among others. In this review, we will provide a general overview of the ECS with emphasis on the CB1 receptor in health and disease. We will describe our current understanding of the complex aspects of receptor signaling and trafficking, including the non-canonical signaling pathways such as those mediated by β-arrestins within the context of functional selectivity and ligand bias. Finally, we will highlight some of the disorders in which CB1 receptors have been implicated. Significant knowledge has been achieved over the last 30 years. However, much more research is still needed to fully understand the complex roles of the ECS, particularly in vivo and to unlock its true potential as a source of therapeutic targets.

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“…If not satisfactory they should be supported as described by Otero-Romero et al [13], adding cannabis-based drugs, peripherally acting injected muscle relaxants (botulinum toxin, local phenol injections) or intrathecal therapies (baclofen or phenol), together with a complete rehabilitation program providing continuous physical therapy.…”

Section: Introductionmentioning

confidence: 99%

Neurophysiological Profile, Walking Performance Tests and Self-Reported Questionnaires in Spastic Patients with MS: A Pilot Study

Calvi¹,

Riz²,

Pietroboni³

2016

J Mult Scler

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Nabiximols is currently being used as an add-on therapeutic option to treat severe forms of multiple sclerosis (MS) spasticity, especially in the progressive phase of the disease.The aim of this exploratory study is to evaluate the response to Nabiximols therapy and modifications in neurophysiological profile, improvement in walking performance tests and self-reported questionnaires, as possible further outcome measures of spasticity.

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Pharmacological management of spasticity in multiple sclerosis: Systematic review and consensus paper

Abstract: Background and objectives: Treatment of spasticity poses a major challenge resulting

Cited by 135 publications

References 86 publications

Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice

Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice

Cannabinoid Receptors in the Central Nervous System: Their Signaling and Roles in Disease

Neurophysiological Profile, Walking Performance Tests and Self-Reported Questionnaires in Spastic Patients with MS: A Pilot Study

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