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

Abstract

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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    Authors+Show Affiliations

    Vermersch P
    ,

    University of Lille, CHU Lille, LIRIC-INSERM U995, FHU Imminent, Lille, France.

    Trojano M

    Source

    European neurology 76:5-6 2016 pg 216-226

    MeSH

    Activities of Daily Living
    Adult
    Baclofen
    Cannabidiol
    Dronabinol
    Drug Combinations
    Female
    Humans
    Italy
    Male
    Middle Aged
    Multiple Sclerosis
    Muscle Spasticity
    Oral Sprays
    Plant Extracts
    Prospective Studies
    Quality of Life

    Pub Type(s)

    Journal Article
    Multicenter Study
    Observational Study

    Language

    eng

    PubMed ID

    27732980

    Citation

    Vermersch, Patrick, and Maria Trojano. "Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice." European Neurology, vol. 76, no. 5-6, 2016, pp. 216-226.
    Vermersch P, Trojano M. Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice. Eur Neurol. 2016;76(5-6):216-226.
    Vermersch, P., & Trojano, M. (2016). Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice. European Neurology, 76(5-6), pp. 216-226.
    Vermersch P, Trojano M. Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice. Eur Neurol. 2016;76(5-6):216-226. PubMed PMID: 27732980.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Tetrahydrocannabinol:Cannabidiol Oromucosal Spray for Multiple Sclerosis-Related Resistant Spasticity in Daily Practice. AU - Vermersch,Patrick, AU - Trojano,Maria, Y1 - 2016/10/13/ PY - 2016/06/14/received PY - 2016/08/04/accepted PY - 2016/10/13/pubmed PY - 2017/9/28/medline PY - 2016/10/13/entrez SP - 216 EP - 226 JF - European neurology JO - Eur. Neurol. VL - 76 IS - 5-6 N2 - 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. SN - 1421-9913 UR - https://www.unboundmedicine.com/medline/citation/27732980/Tetrahydrocannabinol:Cannabidiol_Oromucosal_Spray_for_Multiple_Sclerosis_Related_Resistant_Spasticity_in_Daily_Practice_ L2 - https://www.karger.com?DOI=10.1159/000449413 DB - PRIME DP - Unbound Medicine ER -