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

Abstract

Spasticity is a disabling complication of multiple sclerosis, affecting many patients with the condition. We report the first Phase 3 placebo-controlled study of an oral antispasticity agent to use an enriched study design.

Keywords

• Cannabidiol
• cannabinoids
• delta-9-tetrahydrocannabinol
• endocannabinoid system
• multiple sclerosis
• nabiximols
• Sativex
• spasticity