Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
The clinical primary hypothesis is that there will be a difference between a Cannabis Sativa
extract and placebo in their effect on spasticity in Motor Neuron Disease (MND) patients with
signs of involvement of the upper motor neuron (UMN) resulting in disabling spasticity.
Secondary goals of the study are to evidence of improvement in other symptoms (in particular
pain), and to show favourable trends on functionality measures. Finally, cannabis based drug
safety and tolerability will be studied through vital parameters (including weight and
pulmonary function) measurement, and analyzing ALS function rating scale progression slope
hopefully, showing a slowing of the functional values decrease, owing to cannabis
neuroprotective effects)
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Ospedale San Raffaele
Collaborators:
Fondazione Salvatore Maugeri Niguarda Hospital University of Padova