Sativex Versus Placebo When Added to Existing Treatment for Central Neuropathic Pain in MS
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|ClinicalTrials.gov Identifier: NCT00391079|
Recruitment Status : Completed
First Posted : October 23, 2006
Results First Posted : July 4, 2012
Last Update Posted : June 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Sativex Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||339 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||September 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||September 2008|
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.
Other Name: GW-1000-02
|Placebo Comparator: B||
Containing colourants and excipients. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays.
Other Name: GA0034
- Change in Mean Pain Due to MS NRS Score [ Time Frame: 14 weeks: Baseline - End of Treatment (last 7 days of treatment) ]The pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to multiple sclerosis. A negative value indicates an improvement in pain score from baseline.
- Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Pain Score From Baseline [ Time Frame: 14 weeks: Baseline - end of treatment (last 7 days) ]A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS pain score from baseline to week 14 (last 7 days). The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to multiple sclerosis. The pain NRS was completed at the same time each day, i.e. bedtime in the evening.
- Change in Pain From Baseline to End of the Treatment Using the NPS (Neuropathic Pain Scale) [ Time Frame: 14 weeks: Baseline - End of treatment (Week 14) ]The NPS score is 0-100 sum of 10 individual pain scores (0-10 NRS, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain.
- Change From Baseline to End of Treatment in Break-through Analgesia Usage [ Time Frame: 14 weeks: baseline - end of treatment (last 7 days) ]Use of break through medication was recorded daily during the 14 weeks of the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment.
- Change From Baseline to End of Treatment in BPI (Brief Pain Inventory) Short Form [ Time Frame: 14 weeks: Baseline to end of treatment (last 7 days of treatment) ]The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.
- Change in Subject Global Impression of Change (SGIC) [ Time Frame: Week 14 ]A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to multiple sclerosis since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". At baseline subjects wrote a brief description of their pain caused by multiple sclerosis which was used at Week 14 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.
- Change in Sleep Disruption NRS [ Time Frame: 14 weeks; Baseline to end of treatment (last 7 days) ]The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391079
|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|
|London Health Sciences Centre / University Hospital|
|London, Ontario, Canada, N6A 5A5|
|Ottawa Hospital General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Montreal Neurological Institute|
|Montreal, Quebec, Canada, H3 A 2B4|
|Study Director:||Gerard S Barron, BSc||GW Pharma Ltd|