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

Launched by GW PHARMACEUTICALS LTD · Oct 20, 2006

Keywords

ClinConnect Summary

GW has shown in phase II and III studies that Sativex has analgesic properties that are effective in relieving neuropathic pain. These studies suggested that Sativex is well tolerated and may also improve sleep and quality of life. GW is conducting this study to further demonstrate these effects.

Gender

ALL

Eligibility criteria

• 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