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

At last the Sativex study results in print.

“Most neurologists don’t like the study design used in this trial, i.e. an enrichment design in which only the responders from the first phase were included in the second comparative phase to show the drug worked. It is important to remember that it is impossible to blind a trial that is testing cannabinoids as they have psycho-active effects. The reality of symptomatic therapies is that we always use them in this way in the clinic; i.e. we give someone a therapeutic trial and if they don’t respond or they develop intolerable side effects we stop the drug.”

Novotna et al. Eur J Neurol. 2011 Mar 1. doi: 10.1111/j.1468-1331.2010.03328.x. [Epub ahead of print]

Sativex Trial Design

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