Use of Cannabinoids in Patients With Multiple Sclerosis

Inclusion Criteria: Male or female subjects between 18 and 60 years of age (inclusive) Have definite Multiple Sclerosis as per Poser Criteria Have either relapsing remitting or secondary progressive course Baseline EDSS score from 3.0 to 6.5 (inclusive) Stable disease for at least 30 days prior to study entry Be right-handed with normal right hand function Female patients of child bearing potential and male patients whose partner is of child bearing potential who are willing to ensure that they or their partner use effective contraception during the study and for three months thereafter If female, be neither pregnant nor breast-feeding. Confirmation that the subjects not pregnant must be established by a negative serum hCG pregnancy test at baseline. No cannabinoids use (cannabis, Marinol, Nabilone) for at least three months prior to entry into the study and willing to abstain from any use of cannabis during the study Significant spasticity in at least two muscle groups defined as a score of 2 or more on the Ashworth scale for each muscle group Antispastic/antiepileptic treatments (dosage, frequency and route of administration) stable for at least one month prior the study entry - Exclusion Criteria: Have a primary progressive MS Patients under disease modifying therapies prescribed in the 6 months prior the study entry Patients who have participated in another research study in the past 6 months Changes in antispastic/antiepileptic treatments (dosage, frequency and route of administration) within one month prior the study entry Have a psychiatric disorders or cognitive impairment that preclude safe participation in the study Known history of alcohol or substance abuse Concurrent clinically important immunologic, pulmonary, renal, liver, active thyroid, and/or other major disease other than MS Severe cardiovascular, disorders, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure Patients suffering from acute or chronic pain History of epilepsy Female patient who is pregnant, lactating or planning pregnancy during the course of the study Scheduled elective surgery or other procedures requiring general anaesthesia during the study Patient who is terminally ill or is inappropriate for placebo medication Systemic corticosteroid therapy within 4 weeks of randomization or exacerbation of MS within 30 days Regular levodopa therapy within 7 days of the study entry Male patient currently receiving sildenafil (Viagra) and unwilling to stop medication for the duration of the study Patients who are currently taking antiarrhythmic medications Known or suspected adverse reaction to cannabinoids Travel outside the Italy planned during the study Donation of blood during the study Contraindications to MRI scans -