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Advances in the management of multiple sclerosis spasticity: recent clinical trials.
Eur Neurol 2014; 72 Suppl 1:9-11EN

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.

Authors+Show Affiliations

Neurology Department and 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

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 -