Safety and efficacy of nabiximols on spasticity symptoms in patients with motor neuron disease (CANALS): a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial

Publication date: Available online 13 December 2018Source: The Lancet NeurologyAuthor(s): Nilo Riva, Gabriele Mora, Gianni Sorarù, Christian Lunetta, Ottavia E Ferraro, Yuri Falzone, Letizia Leocani, Raffaella Fazio, Mauro Comola, Giancarlo Comi, Fabio Formaglio, Paolo Rossi, Marta Clerici, Yuri Matteo Falzone, Laura Pozzi, Daniele Martinelli, Federica Cerri, Ignazio Diego Lopez, Filippo Martinelli-Boneschi, Angelo QuattriniSummaryBackgroundSpasticity is a major determinant of disability and decline in quality of life in patients with motor neuron disease. Cannabinoids have been approved for symptomatic treatment of spasticity in multiple sclerosis. We investigated whether cannabinoids might also reduce spasticity in patients with motor neuron disease.MethodsWe did an investigator-initiated, randomised, double-blind, placebo-controlled, phase 2 clinical trial at four tertiary motor neuron disease centres in Italy. Eligible patients were aged 18–80 years; had possible, laboratory-supported probable, probable, or definite amyotrophic lateral sclerosis as defined by revised El Escorial criteria, or primary lateral sclerosis according to Pringle's criteria; had spasticity symptoms due to motor neuron disease for at least 3 months; had spasticity scores of 1 or greater in at least two muscle groups on the Modified Ashworth Scale; and were taking an antispasticity regimen that was maintained at a stable dose for 30 days before enrolment. Participants were assigned (1:1) by an in...
Source: The Lancet Neurology - Category: Neurology Source Type: research