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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01776970
• Date of registration: 24/01/2013
• Prospective Registration: No
• Primary sponsor: Ospedale San Raffaele
• Public title: Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease CANALS
• Scientific title: 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
• Date of first enrolment: January 2013
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01776970
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Italy

Contacts

• Name: Giancarlo Comi, MD
• Affiliation: San Raffaele Scientific Institute

Key inclusion & exclusion criteria

Inclusion criteria:

Subjects must fulfil ALL of the following criteria:

- Written informed consent

- Subject able and willing to comply with all study requirements

- Affected by ALS, either of definite, probable or possible category according to the El
Escorial revised criteria or by primary lateral sclerosis (Pringle's criteria)

- Affected of spasticity, equal or above 1 in the Ashworth Scale for spasticity in 2 or
more muscle groups

- Who will judge spasticity a relevant cause of movements impairment

- Subject has spasticity due to MND of at least three months duration, which is not
wholly relieved with current anti-spasticity therapy

- Subject fulfils at least one of the two criteria below. Subject must be either:

1. Currently established on a regular dose of anti-spasticity therapy, or

2. Previously tried and failed, or could not tolerate suitable anti-spasticity
therapy

- Stabilization of factors affecting spasticity: any physiotherapy regimen or medication
likely to affect spasticity will be optimised before the study and not altered in the
3 weeks before start of treatment

- Subject is willing for his or her name to be notified to the responsible authorities
for participation in this study, as applicable.

Additional inclusion Criteria to be met at baseline

• Subjects have registered spasticity NRS scores via the personal clinical diary over the 6
days (day 2 to day 7) before randomization

Exclusion criteria:

- Any concomitant disease or disorder that has spasticity-like symptoms or that may
influence the subject's level of spasticity

- Subjects receiving Botulinum Toxin during the preceding 6 months

- Bedridden and tracheotomised patients

- Fixed-tendon contractures

- Severe cognitive impairment

- Currently using or has used cannabis, cannabinoid-based medications or Acomplia
(Rimonabant) within 30 days of study entry and unwilling to abstain for the duration
of the study

- Any history or immediate family history of schizophrenia, other psychotic illness,
severe personality disorder or other significant psychiatric disorder other than
depression associated with their underlying condition

- Any known or suspected history of a diagnosed dependence disorder, current heavy
alcohol consumption, current use of an illicit drug or current non-prescribed use of
any prescription drug

- Subjects with poorly controlled epilepsy or recurrent seizures (Subjects who have had
one or more fits in the year prior to Visit 1 will be excluded)

- Any known or suspected hypersensitivity to cannabinoids or any of the excipients

- Subject has experienced myocardial infarction or clinically relevant cardiac
dysfunction within the last 12 months or has a cardiac disorder that, in the opinion
of the investigator would put the subject at risk of a clinically relevant arrhythmia
or myocardial infarction

- Subject has a diastolic blood pressure of <50 mmHg or >105 mmHg (when measured in a
sitting position at rest for five minutes) or a postural drop in the systolic blood
pressure of greater than 20 mmHg

- Personal history suggestive of relevant impaired renal or hepatic function

- Female subjects of child bearing potential, unless willing to ensure that they or
their partner use effective contraception during the study and for three months
thereafter

- Female subject who is pregnant, lactating or planning pregnancy during the course of
the study and for three months thereafter

- Subjects who have received any IMP within the 8 weeks before Visit 1

- Any other significant disease or disorder which, in the opinion of the investigator,
may either put the subject at risk because of participation in the study, or may
influence the result of the study, or the subject's ability to participate in the
study

- Unwilling to abstain from donation of blood during the study

- Patients will be asked not to drive while they will be receiving medication



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis (ALS)

Motor Neuron Disease

Intervention(s)

Drug: Cannabis Sativa extract Oromucosal spray

Primary Outcome(s)

modified 5 - points modified Ashworth scale (AS). [Time Frame: Week 7 (6 weeks after randomization)]

Secondary Outcome(s)

Mean weekly spasticity, spasm frequency and sleep disruption Numeric Rating Scale (NRS) score [Time Frame: Week 7 (6 weeks after randomizazion)]

Secondary ID(s)

CANALS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Padova

Niguarda Hospital

Fondazione Salvatore Maugeri