Trojano M, Vila C. Effectiveness and Tolerability of THC/CBD Oromucosal Spray for Multiple Sclerosis Spasticity in Italy: First Data from a Large Observational Study. Eur Neurol. 2015 Nov 17;74(3-4):178-185
BACKGROUND: The prospective, non-interventional Mobility Improvement (MOVE) 2 study was designed to provide real life data on clinical outcomes of patients with treatment-resistant multiple sclerosis (MS) spasticity receiving routine treatment with tetrahydrocannabinol (THC):cannabidiol (CBD) oromucosal spray (Sativex®), subsequent to its approval in European countries.
METHODS: This interim analysis reports on MOVE 2 patients from Italy.
RESULTS:Interim data from 322 patients (58.3% female; mean age 51.1 ± 10.2 years) were analyzed. From baseline to month 3 of treatment (Visit 3), the mean 0-10 Numerical Rating Scale (NRS) score decreased by -19.1% (-1.6 points, p < 0.0001) and the mean modified Ashworth score decreased from 2.6 to 2.3 points (p < 0.0001). At Visit 3, 24.6% of 203 patients with available data were clinically relevant responders (≥30% improvement from baseline NRS score; p < 0.001 vs. baseline). The mean reported dose of THC:CBD oromucosal spray was 6.1 ± 2.5 sprays/day at Visit 1 (1 month) and 5.1 ± 2.6 sprays/day at Visit 3 (range 1-12 sprays/day at both timepoints). Forty-one (13.1%) patients reported at least one adverse event (AE), which included 3 serious AEs (1 unrelated). AEs with an incidence ≥1% were dizziness (5.6%), confusion (2.5%), nausea (1.25%) and somnolence (1.25%).
CONCLUSION: In everyday clinical practice in Italy, THC:CBD oromucosal spray provided symptomatic relief of MS spasticity with good tolerability in a relevant number of previously resistant patients.
So a good example of how our work in the beasties with EAE, first published in 2000, translated into human benefit. So it shows that everything you do in EAE is not always a waste of time.
This built on a biology that the endocannabinoid system controls excitablity of nerves, so it makes sense that compounds within cannabis can control symptoms that are caused by to much nervous excitation.
In this study they reported an affect on an MSer assessed scale but also showed an effect on the Ashworth scale with is a doctor/physiotherapist- assessed scale of muscle stiffness, that did not show an effect in clinical trials.
CoI: We are developing a compound that would compete against sativex.