Clinical trial NCT00391079: Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Central Neuropathic Pain
Lead sponsor: GWPharm
Sponsor class: UNKNOWN
First posted: 2006-10-23
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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

Primary outcomes:
measure: Change in Mean Pain Due to MS NRS Score
timeFrame: 14 weeks: Baseline - End of Treatment (last 7 days of treatment)
measure: Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline
timeFrame: 14 weeks: Baseline - end of treatment (last 7 days)
Secondary outcomes:
measure: Change in Pain From Baseline to End of the Treatment Using the NPS (Neuropathic Pain Scale)
timeFrame: 14 weeks: Baseline - End of treatment (Week 14)
measure: Change From Baseline to End of Treatment in Break-through Analgesia Usage
timeFrame: 14 weeks: baseline - end of treatment (last 7 days)
measure: Change From Baseline to End of Treatment in BPI (Brief Pain Inventory) Short Form
timeFrame: 14 weeks: Baseline to end of treatment (last 7 days of treatment)
measure: Change in Subject Global Impression of Change (SGIC)
timeFrame: Week 14
measure: Change in Sleep Disruption NRS
timeFrame: 14 weeks; Baseline to end of treatment (last 7 days)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Multiple Sclerosis Program, Foothills Hospital SSB
state: Alberta
city: Vancouver
country: Canada
facility: MS Clinic, UBC Purdy Pavilion
state: British Columbia
city: Halifax
country: Canada
facility: Dalhousie MS Research Clinic
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre / University Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital General Campus
state: Ontario
city: Montreal
country: Canada
facility: Montreal Neurological Institute
state: Quebec
Study officials:
affiliation: GW Pharma Ltd
name: Gerard S Barron, BSc
role: STUDY_DIRECTOR
References:
citation: Langford RM, Mares J, Novotna A, Vachova M, Novakova I, Notcutt W, Ratcliffe S. A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis. J Neurol. 2013 Apr;260(4):984-97. doi: 10.1007/s00415-012-6739-4. Epub 2012 Nov 21.