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Advances in the management of multiple sclerosis spasticity: recent clinical trials.

Abstract

BACKGROUND

Most patients with multiple sclerosis (MS) experience spasticity as the clinical course evolves. Associated symptoms include (often painful) spasms, urinary dysfunction and sleep disturbances. THC:CBD oromucosal spray (Sativex®) is approved for symptom improvement in adult patients with moderate to severe MS-related spasticity who have not responded adequately to other antispasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy.

SUMMARY

In pivotal clinical trials of THC:CBD oromucosal spray, a meaningful proportion of patients with treatment-resistant MS spasticity achieved clinically relevant improvement with active treatment versus placebo. The utility of a 4-week trial of therapy to identify patients who respond to treatment was demonstrated in an enriched-design study. THC:CBD oromucosal spray was well tolerated in these studies, with no evidence of effects typically associated with recreational cannabis use. In a subsequent post approval clinical trial, THC:CBD oromucosal spray had no statistically significant effect on cognition and mood compared with placebo. Moreover, after 50 weeks' treatment, approximately two-thirds of patients, physicians and caregivers reported improvement from baseline in spasticity based on global impressions of change. Key Messages: In phase III clinical trials, approximately one-third of MS patients with treatment-resistant spasticity had a clinically relevant and statistically significant response to THC:CBD oromucosal spray. In addition to a reduction in spasticity, responders experienced meaningful relief from associated symptoms. THC:CBD oromucosal spray was generally well tolerated and efficacy was maintained over the longer term. A post-approval clinical trial indicated no effect of THC:CBD oromucosal spray on cognition or mood after 50 weeks of use.

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  • Authors+Show Affiliations

    Neurology Department and Institute of Clinical Neurosciences, Regional University Hospital, Málaga, Spain.

    Source

    European neurology 72 Suppl 1: 2014 pg 9-11

    MeSH

    Affect
    Cannabidiol
    Clinical Trials, Phase III as Topic
    Cognition
    Dronabinol
    Drug Combinations
    Humans
    Multiple Sclerosis
    Muscle Relaxants, Central
    Muscle Spasticity
    Plant Extracts
    Randomized Controlled Trials as Topic

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    25278117

    Citation

    Fernández, Oscar. "Advances in the Management of Multiple Sclerosis Spasticity: Recent Clinical Trials." European Neurology, vol. 72 Suppl 1, 2014, pp. 9-11.
    Fernández O. Advances in the management of multiple sclerosis spasticity: recent clinical trials. Eur Neurol. 2014;72 Suppl 1:9-11.
    Fernández, O. (2014). Advances in the management of multiple sclerosis spasticity: recent clinical trials. European Neurology, 72 Suppl 1, pp. 9-11. doi:10.1159/000367616.
    Fernández O. Advances in the Management of Multiple Sclerosis Spasticity: Recent Clinical Trials. Eur Neurol. 2014;72 Suppl 1:9-11. PubMed PMID: 25278117.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Advances in the management of multiple sclerosis spasticity: recent clinical trials. A1 - Fernández,Oscar, Y1 - 2014/09/26/ PY - 2014/10/4/entrez PY - 2014/10/4/pubmed PY - 2015/6/13/medline SP - 9 EP - 11 JF - European neurology JO - Eur. Neurol. VL - 72 Suppl 1 N2 - BACKGROUND: Most patients with multiple sclerosis (MS) experience spasticity as the clinical course evolves. Associated symptoms include (often painful) spasms, urinary dysfunction and sleep disturbances. THC:CBD oromucosal spray (Sativex®) is approved for symptom improvement in adult patients with moderate to severe MS-related spasticity who have not responded adequately to other antispasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. SUMMARY: In pivotal clinical trials of THC:CBD oromucosal spray, a meaningful proportion of patients with treatment-resistant MS spasticity achieved clinically relevant improvement with active treatment versus placebo. The utility of a 4-week trial of therapy to identify patients who respond to treatment was demonstrated in an enriched-design study. THC:CBD oromucosal spray was well tolerated in these studies, with no evidence of effects typically associated with recreational cannabis use. In a subsequent post approval clinical trial, THC:CBD oromucosal spray had no statistically significant effect on cognition and mood compared with placebo. Moreover, after 50 weeks' treatment, approximately two-thirds of patients, physicians and caregivers reported improvement from baseline in spasticity based on global impressions of change. Key Messages: In phase III clinical trials, approximately one-third of MS patients with treatment-resistant spasticity had a clinically relevant and statistically significant response to THC:CBD oromucosal spray. In addition to a reduction in spasticity, responders experienced meaningful relief from associated symptoms. THC:CBD oromucosal spray was generally well tolerated and efficacy was maintained over the longer term. A post-approval clinical trial indicated no effect of THC:CBD oromucosal spray on cognition or mood after 50 weeks of use. SN - 1421-9913 UR - https://www.unboundmedicine.com/medline/citation/25278117/Advances_in_the_management_of_multiple_sclerosis_spasticity:_recent_clinical_trials_ L2 - https://www.karger.com?DOI=10.1159/000367616 DB - PRIME DP - Unbound Medicine ER -