Sativex significantly improves symptoms of MS spasticity vs. placebo (1)
The published 16 week pivotal phase III Sativex trial was conducted in subjects who remained on current medication. Phase A (week 1-4); single-blind screening to identify responders: Phase B (week 5-16); randomised double-blind placebo-controlled phase with responders only.
Sativex plus standard of care (SoC) significantly improved spasticity symptoms vs. placebo plus SoC (p=0.0002; ITT population) (1)
74% of patients randomised to Sativex achieved an improvement of ≥30% from baseline by the end of the 16 week study (1)
Result of self-reported primary end-point was confirmed by secondary measures (1)
- Significant improvement with Sativex in additional symptoms associated with spasticity, such as spasm frequency (p=0.005) and sleep disruption (p<0.0001)
- Significant improvement with Sativex vs. placebo in Barthel Activities of Daily Living (p=0.0067)
- Significant improvement with Sativex in physician and carer’s global impression of change (GIC) (p=0.005 and p=0.005, respectively)
- Novotna A et al. Eur J Neurol 2011;18(9):1122-1131.