Table 4

Sativex in a former observational study and clinical trial versus our study: comparison of key parameters

ParametersObservational study (n=300)16Clinical Trial (n=572)12Present study (n=1597)
N300 pts572 pts1597
Female (%)168 (60.9)347 (61)849 (52.6%)
Age (years, mean±SD)50±9.448.9±9.6351±9.5
Disease duration (years, mean±SD)15.4±9.012.4±7.6617.5±8.6
Baseline EDSS6.0 (1–9)*6.0±1.42†6.5 (1.5–9.5)*
NRS T0 in IR (mean±SD)6.4±1.86.9±1.27.6±1.4
NRS T1 in IR (mean±SD)3.9±1.53.9±1.55.3±1.3
Percentage of reduction T0-T140.2%43.5%30.3%
IR after 1 month42%47%70.5%
CRR after 3 months41%36%28.3%
Mean dose (sprays/day)
Adverse events (1 or more)15.4%46.9%16.3%
  • *Median (min–max).

  • †Mean±SD.

  • CRR, clinical relevant response (30% NRS response); EDSS, expanded disability status scale; IR, initial response (20% NRS response); NRS, numerical rating scale for multiple sclerosis spasticity.