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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GW Pharmaceuticals Ltd.
• Treatments: Nabiximols

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