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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2013-06-24
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
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.
GW-1000-02Containing colourants and excipients. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays.
GA0034Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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.
Population: Change in mean daily NRS score
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 167 | -2.02 | 2.15 |
| Placebo | 172 | -1.89 | 2.33 |
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.
Eligibility
primary outcomes
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.
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.
secondary outcomes
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.
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.
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.
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.
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.
Publications
No exact PMID-linked public article is currently readable locally.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 167 | 84 | - |
| Placebo | 172 | 77 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 167 | -14.24 | 18.17 |
| Placebo | 172 | -11.44 | 17.86 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 167 | -1.16 | 1.61 |
| Placebo | 172 | -1.02 | 2.07 |
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.
Population: All subjects who completed the BPI-short form were included in the analysis. Four subjects from the sativex group and three subjects from the placebo group did not complete the form.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 163 | -1.5 | 2.04 |
| Placebo | 169 | -1.4 | 2.09 |
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.
Population: All subjects who completed the question were included in the analysis. Two subjects from the Sativex group and six subjects from the placebo group did not complete the question.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 165 | 13 | - |
| Placebo | 166 | 8 | - |
| Sativex | 165 | 18 | - |
| Placebo | 166 | 15 | - |
| Sativex | 165 | 32 | - |
| Placebo | 166 | 25 | - |
| Sativex | 165 | 29 | - |
| Placebo | 166 | 43 | - |
| Sativex | 165 | 5 | - |
| Placebo | 166 | 5 | - |
| Sativex | 165 | 2 | - |
| Placebo | 166 | 2 | - |
| Sativex | 165 | 1 | - |
| Placebo | 166 | 1 | - |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Sativex | 167 | -1.97 | 2.21 |
| Placebo | 172 | -2.02 | 2.29 |
| Milestone | Sativex | Placebo |
|---|---|---|
| STARTED | 167 | 172 |
| COMPLETED | 141 | 156 |
| NOT COMPLETED | 26 | 16 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Sativex: 1 / 167 · Placebo: 0 / 172 |
| Constipation | Gastrointestinal disorders | Sativex: 0 / 167 · Placebo: 1 / 172 |
| Nausea | Gastrointestinal disorders | Sativex: 0 / 167 · Placebo: 1 / 172 |
| Vomiting | Gastrointestinal disorders | Sativex: 0 / 167 · Placebo: 1 / 172 |
| Hepatic enzyme increased | Investigations | Sativex: 1 / 167 · Placebo: 0 / 172 |
| Motor dysfunction | Nervous system disorders | Sativex: 0 / 167 · Placebo: 1 / 172 |
| Syncope | Nervous system disorders | Sativex: 0 / 167 · Placebo: 1 / 172 |
| Suicidal Ideation | Psychiatric disorders | Sativex: 1 / 167 · Placebo: 0 / 172 |
| Orthostatic hypotension | Vascular disorders | Sativex: 0 / 167 · Placebo: 1 / 172 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Vertigo | Ear and labyrinth disorders | Sativex: 15 / 167 · Placebo: 6 / 172 |
| Nausea | Gastrointestinal disorders | Sativex: 13 / 167 · Placebo: 7 / 172 |
| Dry mouth | Gastrointestinal disorders | Sativex: 12 / 167 · Placebo: 10 / 172 |
| Diarrhoea | Gastrointestinal disorders | Sativex: 7 / 167 · Placebo: 5 / 172 |
| Vomitting | Gastrointestinal disorders | Sativex: 5 / 167 · Placebo: 5 / 172 |
| Fatigue | General disorders | Sativex: 16 / 167 · Placebo: 9 / 172 |
| Feeling Abnormal | General disorders | Sativex: 5 / 167 · Placebo: 2 / 172 |
| Dizziness | Nervous system disorders | Sativex: 34 / 167 · Placebo: 7 / 172 |
| Somnolence | Nervous system disorders | Sativex: 16 / 167 · Placebo: 3 / 172 |
| Headache | Nervous system disorders | Sativex: 7 / 167 · Placebo: 6 / 172 |
| Disturbance in attention | Nervous system disorders | Sativex: 6 / 167 · Placebo: 1 / 172 |
| Dysgeusia | Nervous system disorders | Sativex: 6 / 167 · Placebo: 1 / 172 |
| Memory Impairment | Nervous system disorders | Sativex: 6 / 167 · Placebo: 1 / 172 |
| Balance Disorder | Nervous system disorders | Sativex: 5 / 167 · Placebo: 2 / 172 |
| Psychomotor skills impaired | Nervous system disorders | Sativex: 5 / 167 · Placebo: 0 / 172 |