A Study of Sativex in the Treatment of Central Neuropathic Pain Due to Multiple Sclerosis

Inclusion Criteria:

• Willing and able to give informed consent for participation in the study.
• Male or female subjects aged 18 years or above.
• Diagnosed with any disease sub-type of multiple sclerosis, with relapses/remission notexpected to influence neuropathic pain.
• Duration of multiple sclerosis greater than six months.
• Central neuropathic pain, due to multiple sclerosis, of at least three monthsduration, for which a nociceptive, peripheral neuropathic or psychogenic causeappeared unlikely and was expected to remain stable for the duration of the study.
• Pain score with a severity of four or more on at least four completed Numerical RatingScale scores in the baseline week.
• Regular medication regime for neuropathic pain had been stable during the previous twoweeks, prior to reduction of tricyclic antidepressants, if applicable.
• Willing to reduce the dosage of amitriptyline, or equivalent of other tricyclicantidepressants, to a maximum of 75 mg per day, if applicable.
• No cannabinoid use (cannabis, Marinol or Nabilone) at least seven days before studyentry and willing to abstain from any use of cannabis during the study.
• Female subjects of child bearing potential or male subjects whose partner was of childbearing potential, who were willing to ensure that they or their partner usedeffective contraception during the study and for three months thereafter.
• Able (in the investigators opinion) and willing to comply with all study requirements.
• Willing for his or her name to be notified to the Home Office for participation inthis study.
• Willing for his or her general practitioner and consultant, if appropriate, to benotified of participation in the study.

Exclusion Criteria:

• History of schizophrenia, other psychotic illness, severe personality disorder orother significant psychiatric disorder other than depression associated with theirunderlying condition.
• Concomitant severe non-neuropathic pain or the presence of illness such as diabetesmellitus that could have caused peripheral neuropathic pain.
• Known or strongly suspected alcohol or substance abuse or considered to be at risk ofalcohol or substance abuse by the investigator.
• Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (otherthan well controlled atrial fibrillation), poorly controlled hypertension or severeheart failure.
• History of epilepsy or convulsions.
• Significant renal or hepatic impairment as shown in medical history or indicated byclinical laboratory results from samples taken at baseline.
• Elective surgery or other procedures requiring general anaesthesia scheduled duringthe study.
• Terminal illness.
• Any other significant disease or disorder which, in the opinion of the Investigator,could either have put the subject at risk because of participation in the study, orinfluenced the result of the study, or the subject's ability to participate in thestudy.
• Female subjects who were pregnant, lactating or planning pregnancy during the courseof the study.
• Regular levodopa (Sinemet, Sinemet Plus, Levodopa, L-dopa, Madopar, Benserazide)therapy within seven days of study entry.
• Known or suspected hypersensitivity to cannabinoids or any of the excipients of thestudy medications.
• Known or suspected adverse reaction to cannabinoids.
• Travel outside the UK planned during study.
• Donation of blood during the study.
• Participated in any other pharmacological clinical research study within 30 days ofstudy entry.
• Previously enrolled into this study.