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Sponsored by: |
GW Pharmaceuticals Ltd. |
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Information provided by: | GW Pharmaceuticals Ltd. |
ClinicalTrials.gov Identifier: | NCT00391079 |
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.
Condition | Intervention | Phase |
---|---|---|
Multiple Sclerosis |
Drug: Sativex Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 339 |
Study Start Date: | September 2006 |
Study Completion Date: | September 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: Sativex
Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays (THC 32.5 mg: CBD 30 mg. |
B: Placebo Comparator |
Drug: Placebo
Containing colourants and excipients. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
Multiple Sclerosis Program, Foothills Hospital SSB | |
Calgary, Alberta, Canada, T2N 2T9 | |
Canada, British Columbia | |
MS Clinic, UBC Purdy Pavilion | |
Vancouver, British Columbia, Canada, V6T 2B5 | |
Canada, Nova Scotia | |
Dalhousie MS Research Clinic | |
Halifax, Nova Scotia, Canada, B3H 1V8 | |
Canada, Ontario | |
Ottawa Hospital General Campus | |
Ottawa, Ontario, Canada, K1H 8L6 | |
London Health Sciences Centre / University Hospital | |
London, Ontario, Canada, N6A 5A5 | |
Canada, Quebec | |
Montreal Neurological Institute | |
Montreal, Quebec, Canada, H3 A 2B4 |
Study Director: | Gerard S Barron, BSc | GW Pharma Ltd |
Responsible Party: | GW Pharmaceuticals Ltd. ( Mr Richard Potts/ Clinical Operations Director ) |
Study ID Numbers: | GWMS0501 |
Study First Received: | October 20, 2006 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00391079 |
Health Authority: | Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Czech Republic: State Institute for Drug Control |
Central Neuropathic Pain |
Tetrahydrocannabinol Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Pain Autoimmune Diseases of the Nervous System |
Pathologic Processes Immune System Diseases Nervous System Diseases |