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 (CANALS)

NCT01776970 Phase 2/Phase 3 COMPLETED

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)

Details

Lead sponsor	Ospedale San Raffaele
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	60
Start date	2013-01
Completion	2015-12

Conditions

• Motor Neuron Disease
• Amyotrophic Lateral Sclerosis (ALS)

Interventions

• Cannabis Sativa extract Oromucosal spray

Primary outcomes

• modified 5 - points modified Ashworth scale (AS). — Week 7 (6 weeks after randomization)
  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).

Countries

Italy