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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.

Cannabis-Based Spray Shows Positive Impact on Overactive Bladder Symptoms of Multiple Sclerosis: Presented at ECTRIMS
By Bruce Sylvester

MADRID, SPAIN -- October 3, 2006 -- Treatment with cannabis-based Sativex has a positive and sometimes significant impact on the symptoms of overactive bladder in multiple sclerosis (MS) patients, researchers reported here at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Sativex is an investigational cannabis-based treatment for pain and symptoms of multiple sclerosis. GW Pharmaceuticals, based in Salisbury, United Kingdom, filed a regulatory submission for the drug in the United Kingdom, Spain, Denmark and the Netherlands for symptomatic relief of spasticity in patient with MS.

"We found both a trend toward improvement in incontinence, the primary endpoint of the study, and statistically significant improvements in a number of related secondary endpoints," said investigator Cris S. Constantinescu, MD, PhD, professor of neurology, University of Nottingham, Nottingham, U.K.

Bladder problems are a common feature of MS, with up to 80% of patients reporting voiding dysfunction, the authors noted in their poster, which was presented on September 29th.

In their 10-week, double-blind, randomised, placebo-controlled trial, Dr. Constantinescu and colleagues evaluated 135 patients with MS who reported detrusor overactivity who were treated with either Sativex or placebo.

The primary endpoint of the study was reduction number of daily episodes of urgency incontinence. Secondary endpoints included incidence of nocturia and urgency, overall bladder condition measured on an 11-point numerical rating scale, daytime frequency, quality of life, patient's global impression of change (PGIC) and volume voided.

The decrease in incontinence episode frequency per day favoured the Sativex-treated group but was not statistically significant (-1.08, P = .57), the investigators reported.

Results also showed statistical significance in favour of Sativex for 10 of the 11 secondary/tertiary endpoints, with 4 out of 7 secondary endpoints. These included: reduction in nocturia episodes (-0.28, P = .010); highly statistically significant improvement in patients' opinion of bladder symptom severity (-1.16 points, P = .001); reduction in the number of voids per day (-0.85, P = .007) and PGIC scores, where 83.6% of subjects receiving Sativex compared with 58.2% receiving placebo said that the status of their bladder condition had improved (odds ratio 2.56, P = .005).

Findings for number of urgency episodes in Sativex-treated subjects fell just short of statistical significance (-0.76, P = .071).

For tertiary endpoints, the investigators reported that the number of daytime voids was statistically significant in favour of Sativex (-0.57, P = .044). There was also a trend in favour of Savitex for improvement in quality of life but this did not reach statistical significance, the researchers noted.

The study was supported by GW Pharmaceuticals.

I'll tell you with absolute certainty that cannabis works for spasticity. I smoke small amounts of marijuana at bedtime (and sometimes on the weekends for fun ). When I run out for extended periods I have not only really bad restless legs, but such bad spasticity in my forearms that I can hardly hold a book steady to read. I know it's effective because I have been experiencing this after a few weeks with no MJ and then I smoke some and it is INSTANTLY gone. I can't wait for Sativex to get to the States, but with our lobbyists being so anti-hemp, I can't imagine it will be anytime soon.

Loobie, maybe they'll surprise us. They have to see that there is a medical benefit for those in need.