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

Condition(s) targeted: Multiple Sclerosis

Intervention: Sativex (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: GW Pharmaceuticals Ltd.

Official(s) and/or principal investigator(s):
Gerard S Barron, BSc, Study Director, Affiliation: GW Pharma Ltd

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.

Official title: A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Sativex When Added to the Existing Treatment Regimen, in the Relief of Central Neuropathic Pain in Subjects With Multiple Sclerosis

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

The primary endpoint is the mean pain due to MS NRS score measured at the end of treatment (week 14).

The Numerical Rating Scale (NRS) measure of pain intensity has been selected as the primary efficacy endpoint. Unidimensional pain scales such as the 11-point NRS have been used extensively and validated for somatic and neuropathic pain

Secondary outcome:

Proportion of subjects showing a 30% or more and 50% or more improvement in their primary endpoint scores between baseline and end of treatment

Change in pain from baseline to end of the treatment using the NPS (Neuropathic Pain Scale)

Break-through analgesia usage

BPI (Brief Pain Inventory) short form

SGIC (Subject Global Impression of Change)

Sleep Quality

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Multiple Sclerosis Program, Foothills Hospital SSB, Calgary, Alberta T2N 2T9, Canada

MS Clinic, UBC Purdy Pavilion, Vancouver, British Columbia V6T 2B5, Canada

Dalhousie MS Research Clinic, Halifax, Nova Scotia B3H 1V8, Canada

Ottawa Hospital General Campus, Ottawa, Ontario K1H 8L6, Canada

London Health Sciences Centre / University Hospital, London, Ontario N6A 5A5, Canada

Montreal Neurological Institute, Montreal, Quebec H3 A 2B4, Canada

Starting date: September 2006
Ending date: July 2008
Last updated: April 29, 2008