Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS - Full Text View

Sponsored by:	GW Pharmaceuticals Ltd.
Information provided by:	GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:	NCT00391079

Purpose

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

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Tetrahydrocannabinol Cannabis GW-1000 Cannabidiol

U.S. FDA Resources

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

Further study details as provided by GW Pharmaceuticals Ltd.:

Primary Outcome Measures:

The primary endpoint is the mean pain due to MS NRS score measured at the end of treatment (week 14). [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects showing a 30% or more and 50% or more improvement in their primary endpoint scores between baseline and end of treatment [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Change in pain from baseline to end of the treatment using the NPS (Neuropathic Pain Scale) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Break-through analgesia usage [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
BPI (Brief Pain Inventory) short form [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
SGIC (Subject Global Impression of Change) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Sleep Quality [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391079

Locations

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

Sponsors and Collaborators

GW Pharmaceuticals Ltd.

Investigators

Study Director:

Gerard S Barron, BSc

GW Pharma Ltd

More Information

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

Keywords provided by GW Pharmaceuticals Ltd.:

Central Neuropathic Pain

Study placed in the following topic categories:

Tetrahydrocannabinol
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Pain
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009