Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS

Treatment tested

• Nabiximols

Placebo or sham

• Placebo

Other measures (5)

Inclusion Criteria: * Any disease sub-type of MS of at least two years duration * Central neuropathic pain (CNP) of at least three months and expected to remain stable for the study duration * Moderate CNP defined by NRS pain score at baseline sum to at least 24 * Subject established on or previously tried and failed analgesic therapy for CNP * If receiving disease modifying medications, stable dose for 3 months and maintained for study duration Exclusion Criteria: * Subjects whose identified pain is likely to be nociceptive, musculoskeletal (including spasms) peripheral neuropathic or psychogenic in origin, or due to trigeminal neuralgia. * Other non central neuropathic pain of a severity which is likely to interfere with the patients assessment of CNP * medical history suggests subject is likely to relapse/remit during course of study * history of schizophrenia (including family history), other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with MS * known or suspected history of alcohol abuse, epilepsy or recurrent seizures or hypersensitivity to cannabinoids * travel outside of the country of residence planned during the study * significant cardiac, renal or hepatic impairment * subjects with current recreational cannabis, medicinal cannabis or synthetic cannabinoid based medications within 3 months prior to study entry and unwilling to abstain for the duration of the study

The purpose of this study is to find out if cannabis-based medicine compared to a dummy medicine (placebo that contains no active ingredient) can help the central neuropathic pain patients experience as a result of multiple sclerosis. This type of pain "central neuropathic pain" is described as shooting, stabbing, burning or searing like sensation, which is often worse at night.