Treating spasticity in MS is a big problem; it is very common and the current drugs we use are too sedating and tend to have a negative impact on cognition, which limits their use early on in the course of the disease.
This study compares Sativex (the active ingredient in cannabis) with placebo in a 15-week study. The design of this study is interesting for two reasons: (1) it used an enrichment phase to select responders before randomising them to blinded active comparator stage of the trial; and (2) it used a numeric rating scale (NRS) as the primary outcome rather than the Ashworth scale (the traditional outcome measure in spasticity trials). In summary the change in NRS score and responder-status (defined as a greater than or equal to 30% improvement from baseline) were both significantly superior for Sativex, compared with placebo. Importantly, Sativex appears to be well tolerated in this group of patients with quite advanced MS.
It will be interesting to see if Sativex gets a license based on the results of this trial. The availability of Sativex will allow us to “spread the hope” and offer something to patients in whom our current medications are not enough to control their spasticity.