Cannabinoid-Based drug Savitex Appears Helpful for Spasticity in Multiple Sclerosis: Presented at ECTRIMS
By Bruce Sylvester
MADRID, SPAIN -- October 3, 2006 -- Patients with progressive multiple sclerosis showed statistically significant improvement in spasticity-related symptoms following treatment with the cannabinoid-based drug Savitex, researchers reported here at the 22nd Congress of the European Committee for Treatment and research in Multiple Sclerosis (ECTRIMS).
"Since the subjects were able to self titrate the drug, they chose their own regime and there was remarkable concordance in selected dosing, settling at about 7 to 9 sprays per day," said investigator and presenter Christine Collin, MD, honorary professor in cybernetics and neuropsychology, Reading University, and clinician in acute neurorehabilitation and disabling neurological disorders, Reading, United Kingdom.
In the study, presented on September 28th, there was no evidence of dependence, dose escalation, or significant adverse effects, he said.
Dr. Collin and colleagues used the 15-week study to evaluate the efficacy of standardised whole-plant cannabis medicine (Sativex) in patients with MS. They randomised 337 subjects to Sativex or placebo.
Study endpoints included change in mean spasticity Numerical Rating Scale (NRS) score, spasticity NRS at clinic visits, Modified Ashworth Scale, timed 10-meter walk, Barthel Index of activities of daily living, Clinical Global Impression of Change (CGIC), sleep quality, review of pain, tremor and fatigue, spasm severity and bladder symptoms. Effects of treatment on quality-of-life were also measured using the following questionnaires: EuroQual-5 domain (EQ-5D), the Multiple Sclerosis Quality of Life -- 54 domain (MSQoL-54).
Study subjects had exhibited severe levels of spasticity despite ongoing treatment with the best available antispasticity treatments."
For the primary endpoint of mean NRS spasticity, the researchers reported a statistically significant treatment difference of -0.46 points in favour of Sativex in the per protocol (PP) population (P = .035; 95% CI: -0.88, -0.03). The intention to treat (ITT) population achieved a trend in favour of Sativex, with a treatment difference of -0.23 points (P = .219; 95%CI: -0.59, 0.14).
In the PP population, 36% of patients achieved at least a 30% improvement in spasticity NRS with an odds ratio of 1.74 (95% CI: 0.005, 0.266). The researchers observed a trend toward improvement in spasticity NRS in the ITT population, with an odds ratio of 1.34 in favour of Sativex.
"These findings were supported by the CGIC assessment which was strongly in favour of Sativex (odds ratio 1.25, P = .270; 95% CI: 0.84, 1.85).
Analysis of data for secondary endpoints showed trends favouring Sativex for spasticity and for sleep assessments at clinic visits, Modified Ashworth Scale; timed 10-meter walk, quality of life EQ-5D score, sleep quality, review of pain, tremor, spasm severity and bladder symptoms.
"In the PP population the reduction in symptoms of spasticity in the Sativex-treated group was statistically significant. This did not extend to the ITT populations but in this, and other secondary endpoints, the outcomes were in favour of Sativex," the authors concluded.
The study was supported by GW Pharmaceuticals.
Last edited by scoobyjude
on Wed Oct 04, 2006 9:42 am, edited 1 time in total.