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Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data from a Large Observational Study.

Abstract

BACKGROUND

The prospective, non-interventional Mobility Improvement (MOVE) 2 study was designed to provide real life data on clinical outcomes of patients with treatment-resistant multiple sclerosis (MS) spasticity receiving routine treatment with tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (Sativex®), subsequent to its approval in European countries.

METHODS

This interim analysis reports on MOVE 2 patients from Italy.

RESULTS

Interim data from 322 patients (58.3% female; mean age 51.1 ± 10.2 years) were analyzed. From baseline to month 3 of treatment (Visit 3), the mean 0-10 Numerical Rating Scale (NRS) score decreased by -19.1% (-1.6 points, p < 0.0001) and the mean modified Ashworth score decreased from 2.6 to 2.3 points (p < 0.0001). At Visit 3, 24.6% of 203 patients with available data were clinically relevant responders (≥30% improvement from baseline NRS score; p < 0.001 vs. baseline). The mean reported dose of THC:CBD oromucosal spray was 6.1 ± 2.5 sprays/day at Visit 1 (1 month) and 5.1 ± 2.6 sprays/day at Visit 3 (range 1-12 sprays/day at both timepoints). Forty-one (13.1%) patients reported at least one adverse event (AE), which included 3 serious AEs (1 unrelated). AEs with an incidence ≥1% were dizziness (5.6%), confusion (2.5%), nausea (1.25%) and somnolence (1.25%).

CONCLUSION

In everyday clinical practice in Italy, THC:CBD oromucosal spray provided symptomatic relief of MS spasticity with good tolerability in a relevant number of previously resistant patients.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Italy.

    Source

    European neurology 74:3-4 2015 pg 178-85

    MeSH

    Adult
    Cannabidiol
    Dronabinol
    Drug Combinations
    Female
    Humans
    Italy
    Male
    Middle Aged
    Multiple Sclerosis
    Muscle Spasticity
    Plant Extracts
    Prospective Studies

    Pub Type(s)

    Journal Article
    Observational Study
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    26571097

    Citation

    Trojano, Maria, and Carlos Vila. "Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data From a Large Observational Study." European Neurology, vol. 74, no. 3-4, 2015, pp. 178-85.
    Trojano M, Vila C. Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data from a Large Observational Study. Eur Neurol. 2015;74(3-4):178-85.
    Trojano, M., & Vila, C. (2015). Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data from a Large Observational Study. European Neurology, 74(3-4), pp. 178-85. doi:10.1159/000441619.
    Trojano M, Vila C. Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data From a Large Observational Study. Eur Neurol. 2015;74(3-4):178-85. PubMed PMID: 26571097.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data from a Large Observational Study. AU - Trojano,Maria, AU - Vila,Carlos, Y1 - 2015/11/17/ PY - 2015/08/04/received PY - 2015/10/11/accepted PY - 2015/11/17/entrez PY - 2015/11/17/pubmed PY - 2016/7/19/medline SP - 178 EP - 85 JF - European neurology JO - Eur. Neurol. VL - 74 IS - 3-4 N2 - BACKGROUND: The prospective, non-interventional Mobility Improvement (MOVE) 2 study was designed to provide real life data on clinical outcomes of patients with treatment-resistant multiple sclerosis (MS) spasticity receiving routine treatment with tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (Sativex®), subsequent to its approval in European countries. METHODS: This interim analysis reports on MOVE 2 patients from Italy. RESULTS: Interim data from 322 patients (58.3% female; mean age 51.1 ± 10.2 years) were analyzed. From baseline to month 3 of treatment (Visit 3), the mean 0-10 Numerical Rating Scale (NRS) score decreased by -19.1% (-1.6 points, p < 0.0001) and the mean modified Ashworth score decreased from 2.6 to 2.3 points (p < 0.0001). At Visit 3, 24.6% of 203 patients with available data were clinically relevant responders (≥30% improvement from baseline NRS score; p < 0.001 vs. baseline). The mean reported dose of THC:CBD oromucosal spray was 6.1 ± 2.5 sprays/day at Visit 1 (1 month) and 5.1 ± 2.6 sprays/day at Visit 3 (range 1-12 sprays/day at both timepoints). Forty-one (13.1%) patients reported at least one adverse event (AE), which included 3 serious AEs (1 unrelated). AEs with an incidence ≥1% were dizziness (5.6%), confusion (2.5%), nausea (1.25%) and somnolence (1.25%). CONCLUSION: In everyday clinical practice in Italy, THC:CBD oromucosal spray provided symptomatic relief of MS spasticity with good tolerability in a relevant number of previously resistant patients. SN - 1421-9913 UR - https://www.unboundmedicine.com/medline/citation/26571097/Effectiveness_and_Tolerability_of_THC/CBD_Oromucosal_Spray_for_Multiple_Sclerosis_Spasticity_in_Italy:_First_Data_from_a_Large_Observational_Study_ L2 - https://www.karger.com?DOI=10.1159/000441619 DB - PRIME DP - Unbound Medicine ER -