The Canals study: a randomized, double-blind, placebo-controlled, multicentre study to assess the safety and efficacy on spasticity symptoms of a Cannabis Sativa extract in motor neuron disease patients

BACKGROUND AND AIMS: Spasticity is a one of the major determinant of functional loss and decline in quality of life in ALS and other motor neuron disease (MND) patients. In recent years, several clinical trials have tested the efficacy of cannabis on spasticity in multiple sclerosis. The study's primary was to evaluate the safety, tolerability and efficacy of a Cannabis Sativa extract medium-term treatment (6 weeks) to improve spasticity in ALS and MND patients. METHODS: 60 consecutive patients fulfilling specific inclusion criteria were randomized and double blinded allocated to receive a cannabis extract oral spray or placebo. Primary end-point was improvement in the modified 5- points modified Ashworth Scale (MAS). Secondary Endpoints: spasticity, spasm frequency and sleep disruption (0-10 NRS score); Function: walking ability, functional scores (ALSFRS-R); pain (0-10 NRS score). The Global Impression of Change (GIC) for the patient, carer and clinician. RESULTS: The study drug was well tolerated, none of the patients included withdrew from the study. We observed a positive trend for improvement of all outcome measures in the active drug arm compared to the placebo group, which reached statistical significance for the MAS mean score (p=0.013) and pain NRS (p=0.013). Patients’ GIC demonstrated a significant subjective improvement in 55% of subjects (p=0.001). CONCLUSION: Our pilot study suggests that cannabinoids may represent a valuable option for spasticity treatment in MND patients. Moreover, it may have also additional beneficial effects such as pain relief. Further studies are needed in order to confirm our results. Disclosure: This study has been funded by Fondazione Italiana di Ricerca per la Sclerosi Laterale Amiotrofica (AriSLA, CANALS Project)