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BOSTON -- An objectively measured sign of spasticity in multiple sclerosis (MS) patients was relieved with Sativex, the oromucosal cannabinoid spray, in a small randomized trial reported here.

Mean scores on the modified Ashworth scale, which measures resistance to muscular stretching, for lower limb spasticity improved by 18.2% (SD 33.7%) in patients treated with Sativex for 4 weeks, compared with a 6.7% improvement (SD 26.6%) in patients using a placebo spray (P=0.029 for the between-group difference), according to Letizia Leocani, MD, PhD, of University Hospital San Raffaele in Milan.

Previous studies had shown that Sativex, which combines tetrahydrocannabinol and cannabidiol in equal parts, improved MS patients' self-reported symptoms of spasticity. But indicated that the product is "probably ineffective" for objective spasticity measures.

Hence, the current study -- presented at the European Committee for Treatment and Research in Multiple Sclerosis, held jointly this year with its North American counterpart -- provides new support for Sativex as a useful treatment for MS spasticity, an important manifestation that contributes to disability.

It randomized 43 patients to a 2-week titration period followed by 2 weeks of treatment at stable doses with either placebo or Sativex. Following a 2-week washout period, patients then crossed over to a second 4-week cycle with the other treatment.

Exclusion criteria were other medical or psychiatric illnesses that might interfere with treatment or symptomatology, contraindications to transcranial magnetic stimulation, or THC urine test results indicating previous cannabis use.

Patients must have had progressive MS for at least 1 year and modified Ashworth scores at screening of greater than 1 in at least one limb.

Mean patient age in the study was 48 (SD 7) and mean score on the Expanded Disability Status Scale was 5.7 (SD 0.9, range 3.5 to 6.5).

In addition to modified Ashworth score, patients were evaluated with timed 10-meter walks and neurophysiological measures including motor evoked potentials, intracortical inhibition/facilitation, and the so-called H/M ratio (maximal Hoffmann reflex versus the maximal motor response of the soleus muscle).

A responder analysis showed that, among those achieving at least 20% improvement in modified Ashworth scores, half of participants showed such responses only when receiving Sativex. The remainder were divided among patients responding to both the active drug and placebo and those who only responded to placebo.

Importantly, however, Sativex did not produce significant improvements on outcomes other than the modified Ashworth score. In addition to the objective measures, these included patient-reported pain, sleep, and fatigue.

Leocani said these results indicated that additional research is needed on "the relevance of other spinal and supraspinal mechanisms involved in the physiopathology of spasticity."

Sativex is not approved in the U.S.; it is available in several European countries for relief of MS spasticity.

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