MND: the (Therapeutic) Gap
Nabiximol sprays appear to alleviate symptoms of spasticity in motor neuron disease
Cannabinoids have already been approved for symptomatic treatment of spasticity in patients with multiple sclerosis. Now, a phase 2 clinical trial (CANALS, cannabis sativa extract in amyotrophic lateral sclerosis and other motor neuron disease) in Italy has found evidence that similar effects might be seen in patients with motor neuron disease (MND) – a condition where treatments have remained elusive.
“There is no cure for motor neuron disease, so improved symptom control and quality of life are important for patients,” said research lead Nilo Riva (San Raffaele Scientific Institute in Milan, Italy) in a press release.
The researchers studied the effect of nabiximols (a cannabis extract delivered by oromucosal spray) on a key clinical outcome: the Modified Ashworth Scale – an objective measure of spasticity. In the multicenter, double-blind, randomized trial, 59 patients with amyotrophic lateral sclerosis or primary lateral sclerosis were able to self-administer mouth spray containing either nabiximols or a placebo. The results? In brief, the nabiximols group exhibited a reduction in the frequency and severity of spasticity symptoms compared with the placebo group. In addition, the drug was well tolerated (no participants withdrew from the study) and no serious adverse effects occurred; although many experienced symptoms typical of cannabinoids, namely, asthenia (loss of energy), somnolence (sleepiness), vertigo, and nausea.
Despite encouraging phase 2 results, Riva is cautious about extrapolating too much from the study. “We must first confirm that THC-CBD spray is effective and safe in larger, longer term phase 3 trials,” he said. Marine de Visser, a specialist in neurodegerative disorders at The University of Amsterdam, the Netherlands, agreed: “Further studies are needed to establish the frequency of spasticity in the various presentations of MND, and to determine if reductions in spasticity improve overall quality of life. Larger multicenter trials should be done to identify which subgroups of patients might derive clinically significant benefits from nabiximols.”
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