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Advances in the management of MS spasticity: recent observational studies.
Eur Neurol 2014; 72 Suppl 1:12-4EN

Abstract

BACKGROUND

Clinical trials demonstrate the efficacy and tolerability of an intervention under experimental conditions, but information on use under daily practice conditions is required to confirm the effectiveness and safety of new management options.

SUMMARY

Clinical outcomes for THC:CBD oromucosal spray (Sativex®) in patients with treatment-resistant MS spasticity have been collected in post-marketing safety registries from the UK and Germany, a safety study from Spain and two observational studies from Germany, including one investigating its effects on driving ability. Collectively, findings from daily practice support the long-term effectiveness and safety of THC:CBD oromucosal spray. The proportion of patients with a clinically relevant response (≥30% improvement from baseline on the spasticity 0-10 Numerical Rating Scale) at 3 months was similar to that reported in a large enriched-design pivotal clinical trial (41 vs. 36%). There was no evidence of abuse/misuse or other adverse events of special interest with a cannabis-based medicine and no impairment of driving ability. In actual clinical practice, average daily doses were ∼25% lower than those used in clinical trials. Key Messages: Observational data and real world experience reinforce the efficacy and safety of THC:CBD oromucosal spray as reported in phase III clinical trials. © 2014 S. Karger AG, Basel.

Authors+Show Affiliations

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

Pub Type(s)

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

Language

eng

PubMed ID

25278118

Citation

Fernández, Oscar. "Advances in the Management of MS Spasticity: Recent Observational Studies." European Neurology, vol. 72 Suppl 1, 2014, pp. 12-4.
Fernández O. Advances in the management of MS spasticity: recent observational studies. Eur Neurol. 2014;72 Suppl 1:12-4.
Fernández, O. (2014). Advances in the management of MS spasticity: recent observational studies. European Neurology, 72 Suppl 1, pp. 12-4. doi:10.1159/000367618.
Fernández O. Advances in the Management of MS Spasticity: Recent Observational Studies. Eur Neurol. 2014;72 Suppl 1:12-4. PubMed PMID: 25278118.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Advances in the management of MS spasticity: recent observational studies. A1 - Fernández,Oscar, Y1 - 2014/09/26/ PY - 2014/10/4/entrez PY - 2014/10/4/pubmed PY - 2015/6/13/medline SP - 12 EP - 4 JF - European neurology JO - Eur. Neurol. VL - 72 Suppl 1 N2 - BACKGROUND: Clinical trials demonstrate the efficacy and tolerability of an intervention under experimental conditions, but information on use under daily practice conditions is required to confirm the effectiveness and safety of new management options. SUMMARY: Clinical outcomes for THC:CBD oromucosal spray (Sativex®) in patients with treatment-resistant MS spasticity have been collected in post-marketing safety registries from the UK and Germany, a safety study from Spain and two observational studies from Germany, including one investigating its effects on driving ability. Collectively, findings from daily practice support the long-term effectiveness and safety of THC:CBD oromucosal spray. The proportion of patients with a clinically relevant response (≥30% improvement from baseline on the spasticity 0-10 Numerical Rating Scale) at 3 months was similar to that reported in a large enriched-design pivotal clinical trial (41 vs. 36%). There was no evidence of abuse/misuse or other adverse events of special interest with a cannabis-based medicine and no impairment of driving ability. In actual clinical practice, average daily doses were ∼25% lower than those used in clinical trials. Key Messages: Observational data and real world experience reinforce the efficacy and safety of THC:CBD oromucosal spray as reported in phase III clinical trials. © 2014 S. Karger AG, Basel. SN - 1421-9913 UR - https://www.unboundmedicine.com/medline/citation/25278118/Advances_in_the_management_of_MS_spasticity:_recent_observational_studies_ L2 - https://www.karger.com?DOI=10.1159/000367618 DB - PRIME DP - Unbound Medicine ER -