Status:
COMPLETED
Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS
Lead Sponsor:
GW Pharmaceuticals Ltd
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
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 imp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
339 Patients enrolled
Trial Details
Trial ID
NCT00391079
Start Date
September 1 2006
End Date
September 1 2008
Last Update
June 24 2013
Active Locations (6)
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1
Multiple Sclerosis Program, Foothills Hospital SSB
Calgary, Alberta, Canada, T2N 2T9
2
MS Clinic, UBC Purdy Pavilion
Vancouver, British Columbia, Canada, V6T 2B5
3
Dalhousie MS Research Clinic
Halifax, Nova Scotia, Canada, B3H 1V8
4
London Health Sciences Centre / University Hospital
London, Ontario, Canada, N6A 5A5