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New Data For Moderate Patients

New data for moderate patients – SAVANT clinical trial sub-analysis from Dr. Meuth

Tetrahydrocannabinol and cannabidiol oromucosal spray in resistant multiple sclerosis spasticity: consistency of response across subgroups from the SAVANT randomized clinical trial

ORIGINAL CLINICAL TRIAL OBJECTIVES:

To determine whether the severity of resistant MS spasticity patients ́ disability status, spasticity or spasticity duration at the start of treatment might influence MS spasticity improvement possibilities.

STUDY DESIGN:

Prospective, parallel-group, randomized, double-blind, placebo-controlled two-phase trial with 210 MS patients

infographic-trial-design.png

NEW SUBGROUP ANALYSIS KEY ENDPOINTS:

  • Evolution in mean MS spasticity 0-10 NRS scores and mean pain 0-10 NRS scores in the ITT population was analyzed from double-blind treatment data in subgroups of patients stratified according to:

    • EDSS score < 6 (ambulatory) or ≥ 6 at randomization.
    • Spasticity 0-10 NRS score ≤ 6 (4-6: moderate spasticity) or > 6 (severe spasticity) at randomization or

    • Years with MS spasticity (≤ 5 or > 5 years) at randomization.
    • Least squares (LS) mean change from baseline to week 12 randomized phase of the clinical trial (phase B).

NRS, Numerical Rating Scale (spasticity 0-10 NRS score).
EDSS, Expanded Disability Status Scale.
MS, multiple sclerosis.

RESULTS:

  • THC:CBD oromucosal spray halved mean severity scores for spasticity and pain in all subgroups.
  • Statistical comparisons in these post-hoc analyses were affected by the limited sample size at certain subgroups
  • Active treatment significantly improved mean spasticity severity scores versus placebo from week 4 onwards in both EDSS subgroups, in the severe spasticity subgroup, and in both spasticity duration subgroups.
  • Active treatment significantly improved mean pain severity scores versus placebo in the >6 EDSS subgroup, in the severe spasticity subgroup and in both spasticity duration subgroups.

CONCLUSION:

  • Add-on THC:CBD oromucosal spray consistently relieves resistant spas- ticity across subgroups defined by baseline EDSS score, spasticity severity NRS score and spasticity duration.
  • Patients with moderate resistant MS spasticity benefit numerically from treatment; patients with severe resistant spasticity achieve significant therapeutic gains.
  • Spasticity-associated pain often improves similarly in the same subgroups.
  1. Markova 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 Feb;129(2):119-128.
  2. Meuth S, Henze T, Essner U, Trompke C, Vila C. Tetrahydrocannabinol and cannabidiol oromucosal spray in resistant multiple sclerosis spasticity: predictors of response from the SAVANT randomized clinical trial. [Unpublished; pending approval]. 2019.

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