Tags

Type your tag names separated by a space and hit enter

Nabiximols (THC/CBD oromucosal spray, Sativex®) in clinical practice--results of a multicenter, non-interventional study (MOVE 2) in patients with multiple sclerosis spasticity.
Eur Neurol. 2014; 71(5-6):271-9.EN

Abstract

BACKGROUND

Nabiximols (Sativex®), a cannabinoid-based oromucosal spray, is an add-on therapy for patients with moderate to severe multiple sclerosis spasticity (MSS) resistant to other medications. The primary objective was to provide real-life observational data of clinical experience of nabiximols in contrast to formal clinical trials of effectiveness.

METHODS

This was an observational, prospective, multicenter, non-interventional study with a follow-up period of 3-4 months, conducted in routine care setting in Germany. Patients with moderate to severe MSS were included at nabiximols' initiation. Structured documentation forms, questionnaires and validated instruments were used for data collection at inclusion, 1 and 3 months after inclusion.

RESULTS

Overall, 335 patients were assessed of whom 276 fitted the criteria and were included in the effectiveness analysis. After 1 month, nabiximols provided relief of resistant MSS in 74.6% of patients according to specialist assessment; mean spasticity 0-10 numerical rating scale (NRS) score decreased from 6.1 ± 1.8 to 5.2 ± 2.0 points; in patients with NRS improvement ≥20% mean NRS score decreased by 40%. After 3 months, 55.3% of patients had continued to use nabiximols and the mean NRS score had decreased by 25% from baseline. 17% of patients reported adverse events.

CONCLUSION

Real-life data confirm nabiximols as an effective and well-tolerated treatment option for resistant MSS in clinical practice.

Authors+Show Affiliations

Neurological Rehabilitation Center Quellenhof, Bad Wildbad, Germany.No affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24525548

Citation

Flachenecker, Peter, et al. "Nabiximols (THC/CBD Oromucosal Spray, Sativex®) in Clinical Practice--results of a Multicenter, Non-interventional Study (MOVE 2) in Patients With Multiple Sclerosis Spasticity." European Neurology, vol. 71, no. 5-6, 2014, pp. 271-9.
Flachenecker P, Henze T, Zettl UK. Nabiximols (THC/CBD oromucosal spray, Sativex®) in clinical practice--results of a multicenter, non-interventional study (MOVE 2) in patients with multiple sclerosis spasticity. Eur Neurol. 2014;71(5-6):271-9.
Flachenecker, P., Henze, T., & Zettl, U. K. (2014). Nabiximols (THC/CBD oromucosal spray, Sativex®) in clinical practice--results of a multicenter, non-interventional study (MOVE 2) in patients with multiple sclerosis spasticity. European Neurology, 71(5-6), 271-9. https://doi.org/10.1159/000357427
Flachenecker P, Henze T, Zettl UK. Nabiximols (THC/CBD Oromucosal Spray, Sativex®) in Clinical Practice--results of a Multicenter, Non-interventional Study (MOVE 2) in Patients With Multiple Sclerosis Spasticity. Eur Neurol. 2014;71(5-6):271-9. PubMed PMID: 24525548.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nabiximols (THC/CBD oromucosal spray, Sativex®) in clinical practice--results of a multicenter, non-interventional study (MOVE 2) in patients with multiple sclerosis spasticity. AU - Flachenecker,Peter, AU - Henze,Thomas, AU - Zettl,Uwe K, Y1 - 2014/02/12/ PY - 2013/07/23/received PY - 2013/11/17/accepted PY - 2014/2/15/entrez PY - 2014/2/15/pubmed PY - 2015/1/8/medline SP - 271 EP - 9 JF - European neurology JO - Eur. Neurol. VL - 71 IS - 5-6 N2 - BACKGROUND: Nabiximols (Sativex®), a cannabinoid-based oromucosal spray, is an add-on therapy for patients with moderate to severe multiple sclerosis spasticity (MSS) resistant to other medications. The primary objective was to provide real-life observational data of clinical experience of nabiximols in contrast to formal clinical trials of effectiveness. METHODS: This was an observational, prospective, multicenter, non-interventional study with a follow-up period of 3-4 months, conducted in routine care setting in Germany. Patients with moderate to severe MSS were included at nabiximols' initiation. Structured documentation forms, questionnaires and validated instruments were used for data collection at inclusion, 1 and 3 months after inclusion. RESULTS: Overall, 335 patients were assessed of whom 276 fitted the criteria and were included in the effectiveness analysis. After 1 month, nabiximols provided relief of resistant MSS in 74.6% of patients according to specialist assessment; mean spasticity 0-10 numerical rating scale (NRS) score decreased from 6.1 ± 1.8 to 5.2 ± 2.0 points; in patients with NRS improvement ≥20% mean NRS score decreased by 40%. After 3 months, 55.3% of patients had continued to use nabiximols and the mean NRS score had decreased by 25% from baseline. 17% of patients reported adverse events. CONCLUSION: Real-life data confirm nabiximols as an effective and well-tolerated treatment option for resistant MSS in clinical practice. SN - 1421-9913 UR - https://www.unboundmedicine.com/medline/citation/24525548/Nabiximols__THC/CBD_oromucosal_spray_Sativex®__in_clinical_practice__results_of_a_multicenter_non_interventional_study__MOVE_2__in_patients_with_multiple_sclerosis_spasticity_ L2 - https://www.karger.com?DOI=10.1159/000357427 DB - PRIME DP - Unbound Medicine ER -