A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex^®), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis

Abstract

The enriched study design provides a method of determining the efficacy and safety of nabiximols in a way that more closely reflects proposed clinical practice, by limiting exposure to those patients who are likely to benefit from it. Hence, the difference between active and placebo should be a reflection of efficacy and safety in the population intended for treatment.