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Sativex® as add-on therapy vs. further optimized first-line ANTispastics (SAVANT) in resistant multiple sclerosis spasticity: a double-blind, placebo-controlled randomised clinical trial.
Int J Neurosci. 2019 Feb; 129(2):119-128.IJ

Abstract

Purpose/aim: To evaluate the efficacy of tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (Sativex®) as add-on therapy to optimised standard antispasticity treatment in patients with moderate to severe multiple sclerosis (MS) spasticity.

METHODS

Sativex® as add-on therapy vs. further optimised first-line ANTispastics (SAVANT) was a two-phase trial. In Phase A, eligible patients received add-on THC:CBD spray for 4 weeks to identify initial responders [≥20% improvement from baseline in spasticity 0-10 numerical rating scale (NRS) score]. Following washout, eligible initial responders were randomised to receive THC:CBD spray or placebo for 12 weeks (double-blinded, Phase B). Optimisation of underlying antispasticity medications was permitted in both groups across all study periods.

RESULTS

Of 191 patients who entered Phase A, 106 were randomised in Phase B to receive add-on THC:CBD spray (n = 53) or placebo (n = 53). The proportion of clinically relevant responders after 12 weeks (≥30% NRS improvement; primary efficacy endpoint) was significantly greater with THC:CBD spray than placebo (77.4 vs. 32.1%; p < 0.0001). Compared with placebo, THC:CBD spray also significantly improved key secondary endpoints: changes in mean spasticity NRS (p < 0.0001), mean pain NRS (p = 0.0013), and mean modified Ashworth's scale (p = 0.0007) scores from Phase B baseline to week 12. Adverse events, when present, were mild/moderate and without new safety concerns.

CONCLUSIONS

Add-on THC:CBD oromucosal spray provided better and clinically relevant improvement of resistant MS spasticity compared with adjusting first-line antispasticity medication alone.

Authors+Show Affiliations

a Neurology Department , Thomayer's Hospital , Praha , Czechia.b O. Meany Consultancy GmbH , Hamburg , Germany.c Market Access Manager , Almirall Hermal GmbH , Reinbek , Germany.d Clinical Statistics , Almirall S.A. , Barcelona , Spain.e International Clinical Trial Managers , Almirall Hermal GmbH , Reinbek , Germany.e International Clinical Trial Managers , Almirall Hermal GmbH , Reinbek , Germany.f Neurology Medical Manager , Global Medical Affairs, Almirall S.A. , Barcelona , Spain.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29792372

Citation

Markovà, Jolana, et al. "Sativex® as Add-on Therapy Vs. Further Optimized First-line ANTispastics (SAVANT) in Resistant Multiple Sclerosis Spasticity: a Double-blind, Placebo-controlled Randomised Clinical Trial." The International Journal of Neuroscience, vol. 129, no. 2, 2019, pp. 119-128.
Markovà J, Essner U, Akmaz B, et al. Sativex® as add-on therapy vs. further optimized first-line ANTispastics (SAVANT) in resistant multiple sclerosis spasticity: a double-blind, placebo-controlled randomised clinical trial. Int J Neurosci. 2019;129(2):119-128.
Markovà, J., Essner, U., Akmaz, B., Marinelli, M., Trompke, C., Lentschat, A., & Vila, C. (2019). Sativex® as add-on therapy vs. further optimized first-line ANTispastics (SAVANT) in resistant multiple sclerosis spasticity: a double-blind, placebo-controlled randomised clinical trial. The International Journal of Neuroscience, 129(2), 119-128. https://doi.org/10.1080/00207454.2018.1481066
Markovà J, et al. Sativex® as Add-on Therapy Vs. Further Optimized First-line ANTispastics (SAVANT) in Resistant Multiple Sclerosis Spasticity: a Double-blind, Placebo-controlled Randomised Clinical Trial. Int J Neurosci. 2019;129(2):119-128. PubMed PMID: 29792372.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sativex® as add-on therapy vs. further optimized first-line ANTispastics (SAVANT) in resistant multiple sclerosis spasticity: a double-blind, placebo-controlled randomised clinical trial. AU - Markovà,Jolana, AU - Essner,Ute, AU - Akmaz,Bülent, AU - Marinelli,Marcella, AU - Trompke,Christiane, AU - Lentschat,Arnd, AU - Vila,Carlos, Y1 - 2018/09/13/ PY - 2018/5/25/pubmed PY - 2019/4/23/medline PY - 2018/5/25/entrez KW - Multiple sclerosis KW - Sativex KW - THC:CBD KW - nabiximols KW - spasticity SP - 119 EP - 128 JF - The International journal of neuroscience JO - Int. J. Neurosci. VL - 129 IS - 2 N2 - : Purpose/aim: To evaluate the efficacy of tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (Sativex®) as add-on therapy to optimised standard antispasticity treatment in patients with moderate to severe multiple sclerosis (MS) spasticity. METHODS: Sativex® as add-on therapy vs. further optimised first-line ANTispastics (SAVANT) was a two-phase trial. In Phase A, eligible patients received add-on THC:CBD spray for 4 weeks to identify initial responders [≥20% improvement from baseline in spasticity 0-10 numerical rating scale (NRS) score]. Following washout, eligible initial responders were randomised to receive THC:CBD spray or placebo for 12 weeks (double-blinded, Phase B). Optimisation of underlying antispasticity medications was permitted in both groups across all study periods. RESULTS: Of 191 patients who entered Phase A, 106 were randomised in Phase B to receive add-on THC:CBD spray (n = 53) or placebo (n = 53). The proportion of clinically relevant responders after 12 weeks (≥30% NRS improvement; primary efficacy endpoint) was significantly greater with THC:CBD spray than placebo (77.4 vs. 32.1%; p < 0.0001). Compared with placebo, THC:CBD spray also significantly improved key secondary endpoints: changes in mean spasticity NRS (p < 0.0001), mean pain NRS (p = 0.0013), and mean modified Ashworth's scale (p = 0.0007) scores from Phase B baseline to week 12. Adverse events, when present, were mild/moderate and without new safety concerns. CONCLUSIONS: Add-on THC:CBD oromucosal spray provided better and clinically relevant improvement of resistant MS spasticity compared with adjusting first-line antispasticity medication alone. SN - 1563-5279 UR - https://www.unboundmedicine.com/medline/citation/29792372/Sativex®_as_add_on_therapy_vs__further_optimized_first_line_ANTispastics__SAVANT__in_resistant_multiple_sclerosis_spasticity:_a_double_blind_placebo_controlled_randomised_clinical_trial_ L2 - http://www.tandfonline.com/doi/full/10.1080/00207454.2018.1481066 DB - PRIME DP - Unbound Medicine ER -