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 - ND

• Register: EUCTR
• Last refreshed on: 27 January 2014
• Main ID: EUCTR2010-022808-40-IT
• Date of registration: 02/02/2011
• Prospective Registration: No
• Primary sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
• Public 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 - ND
• 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 - ND
• Date of first enrolment: 13/01/2011
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022808-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion criteria:
1) Subject is willing and able to give written informed consent for participation in the study 2) Subject is able (in the investigator’s opinion) and willing to comply with all study requirements. 3) Age between 18 and 80 years 4) Affected by ALS, either of definite, probable or possible category according to the El Escorial revised criteria or by primary lateral sclerosis, according to Pringle’s criteria; 5) Affected of spasticity, equal or above 1 in the Ashworth Scale for spasticity in 2 or more muscle groups; 6) Who will judge spasticity a relevant cause of movements impairment 7) Subject has spasticity due to MND of at least three months duration, which is not wholly relieved with current anti-spasticity therapy, and which is expected to remain stable for the duration of the study. 8) Subject fulfils at least one of the two criteria below. Subject must be either: - Currently established on a regular dose of anti-spasticity therapy, or - Previously tried and failed, or could not tolerate suitable anti-spasticity therapy 9) Subject is currently receiving a stable regimen (for at least 30 days prior to study entry) of all medications that may have an effect on spasticity and is willing to maintain this for the duration of the study. 10) 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 11) Subject is willing to allow his or her primary care physician and consultant, if appropriate, to be notified of participation in the study. 12) 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 1. Subjects have registered spasticity NRS scores via the personal clinical diary over the 6 days (day 2 to Aday 7) Subjects who are non-compliant will be deemed ineligible to continue. 2. The subject has not had the introduction of any new anti-spasticity medication or any alteration to the dosage of anti-spasticity medication during week 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Any concomitant disease or disorder that has spasticity-like symptoms or that may influence the subject’s level of spasticity. 2. Subjects receiving Botulinum Toxin during the preceding six months. 3. bedridden and tracheotomised patients. 4. Fixed-tendon contractures 5. Severe cognitive impairment 6. 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. 7. 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. 8. 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. 9. 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). 10. Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP. 11. 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. 12. 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 at Visit 1. 13. Personal history suggestive of relevant impaired renal or hepatic function at Visit 1. 14. 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. 15. Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter 16. Subjects who have received any IMP within the 8 weeks before Visit 1. 17. 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 18. Following a physical examination, the subject has any abnormalities that, in the opinion of the investigator, would prevent them from safely participating in the study. 19. Unwilling to abstain from donation of blood during the study. 20. Patients will be asked not to drive while they will be receiving medication and, if unable to comply, will be excluded


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

amyotrophic lateral sclerosis
MedDRA version: 9.1 Level: PT Classification code 10002026

Intervention(s)

Trade Name: sativex
Pharmaceutical Form: Oromucosal spray
INN or Proposed INN: sativex
Concentration unit: µl microlitre(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Oromucosal spray
Route of administration of the placebo: Buccal use

Primary Outcome(s)

Primary end point(s): punteggio della scala di Ashworth modificata

Secondary Objective: to evidence a subjective improvement in spasticity and other symptoms (in particular pain), and to show favourable trends on functionality measures.

Main Objective: to evaluate the efficacy and feasibility of a Cannabis Sativa extract (Sativex) treatment to improve spasticity in Motor Neuron Disease (MND) parients with signs of involvement of the upper motor neuron (UMN) resulting in desabling spasticity (ALS and PLS patients).

Secondary ID(s)

CANALS