Cannabis Sativa extract Oromucosal spray, containing THC (27 mg/ml):CBD (25 mg/ml)

Motor Neuron Disease

Amyotrophic Lateral Sclerosis (ALS)

Comparison between active drug (Cannabis Sativa extract Oromucosal spray, containing THC (27 mg/ml):CBD (25 mg/ml) vs placebo

Cannabis Sativa extract Oromucosal spray

San Raffaele Scientific Institute

Fondazione Salvatore Maugeri IRCCS, Istituto Scientifico

NEuroMuscular Omnicentre (NEMO), Fondazione Serena - H Cà granda

Universita' Degli Studi Di Padova, Azienda Ospedaliera Di Padova, Neurologic Department;

Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease

A Fase II, Randomized, Double-Blind, Placebo-Controlled, Multicentre Study for the Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease Patients

Improvement in the modified 5 - points modified Ashworth scale (AS). The variable for analysis will be the change in AS from the baseline (visit 2, Week 2) to the end of treatment (visit 4, Week 7).

Mean weekly spasticity, spasm frequency and sleep disruption NRS score at the end of treatment. The variable for analysis will be the change in mean NRS from the baseline (days 0-7) to the last week of treatment (usually days 42-49). Proportion of subjects completing the study and showing an improvement of 30% or more and 50% or more in NRS from Baseline (Week 1) and end of study (last seven days of treatment)

Pain will be measured with the mean of the last 3 days 0 - 10 daily pain intensity NRS.

Weight difference before and at the end of the study.

The time taken for the 10-metre walk, ALS-FRS and Barthel ADL Index will be analysed using the Visit 2 (week 1)result as baseline.

Carer Global Impression of Change and ease of transfer Physician Global Impression of Change Subject Global Impression of Change

asthenia/cannabis

Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease

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