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To investigate the ability of a cannabis based medicine extract to relieve chronic refractory pain of neurological origin.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-01-10
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
Patients with Multiple Sclerosis or other defect of neurological function with a qualifying symptom of chronic refractory pain, entered a seven day baseline period, followed by a 21 day randomised, double blind, parallel group comparison of GW-1000-02 with placebo, self-titrated to symptom resolution or maximum tolerated dose. The ability of the cannabis based medicine extract to relieve chronic refractory pain was assessed by the change from baseline in pain score using Box Scale-11 (BS-11) scores recorded in the patients' daily diary.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Each actuation of GW-1000-02 (100 μl) delivered a dose containing 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose of study medication was eight actuations in any three hour period (20 mg THC/20 mg CBD) and 48 actuations in any 24 hour period (120 mg THC/120 mg CBD).
SativexEach actuation of placebo (100 μl) delivered the excipients only. The maximum permitted dose of study medication was eight actuations in any three hour period and 48 actuations in any 24 hour period.
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.
Population: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 36 | -1.3 | 1.67 |
| Placebo | 34 | -0.9 | 1.62 |
Eligibility
primary outcomes
Time frame: 0 - 3 weeks
Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.
secondary outcomes
Time frame: 0 - 3 weeks
The percentage of days on treatment on which escape medication was used is presented.
Time frame: 0 - 3 weeks
Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as "No", "Once", "Twice", "More than twice" and "Awake most of the night"; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.
Time frame: 0 - 3 weeks
The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero "no disability" to 10 "total disability" scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.
Time frame: 0 - 3 weeks
The Brief Pain Inventory (Short Form) 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 reduction in score from baseline indicates an improvement.
Time frame: 0 - 3 weeks
The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.
Publications
No exact PMID-linked public article is currently readable locally.
The percentage of days on treatment on which escape medication was used is presented.
Population: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 36 | 20.57 | 33.08 |
| Placebo | 34 | 50.12 | 44.10 |
Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as "No", "Once", "Twice", "More than twice" and "Awake most of the night"; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.
Population: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 36 | -0.57 | 0.85 |
| Placebo | 34 | -0.34 | 0.58 |
The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero "no disability" to 10 "total disability" scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.
Population: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 28 | -5.9 | 10.17 |
| Placebo | 26 | -3.2 | 9.77 |
The Brief Pain Inventory (Short Form) 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 reduction in score from baseline indicates an improvement.
Population: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 34 | -3.6 | 5.12 |
| Placebo | 34 | -1.9 | 6.52 |
The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.
Population: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 33 | -0.2 | 1.17 |
| Placebo | 31 | -0.4 | 1.54 |
The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as "Very Much Improved", "Much Improved", "Minimally Improved", "No Change", "Minimally Worse", "Much Worse" and "Very Much Worse" and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being "Very Much Improved" or "Much Improved" is presented.
Population: All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 36 | 9 | - |
| Placebo | 34 | 9 | - |
Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.
Population: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 24 | -1.6 | 1.90 |
| Placebo | 19 | -0.8 | 1.60 |
The percentage of days on treatment on which escape medication was used is presented.
Population: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 24 | 16.71 | 28.55 |
| Placebo | 19 | 48.48 | 46.63 |
Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as "No", "Once", "Twice", "More than twice" and "Awake most of the night"; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.
Population: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 24 | -0.60 | 0.89 |
| Placebo | 19 | -0.36 | 0.56 |
The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero "no disability" to 10 "total disability" scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.
Population: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 17 | -7.8 | 11.26 |
| Placebo | 16 | -1.7 | 6.98 |
The Brief Pain Inventory (Short Form) 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 reduction in score from baseline indicates an improvement.
Population: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 23 | -4.5 | 5.60 |
| Placebo | 19 | -0.5 | 5.06 |
The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.
Population: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 21 | -0.1 | 1.01 |
| Placebo | 17 | 0.1 | 1.64 |
The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as "Very Much Improved", "Much Improved", "Minimally Improved", "No Change", "Minimally Worse", "Much Worse" and "Very Much Worse" and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being "Very Much Improved" or "Much Improved" is presented.
Population: Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 24 | 6 | - |
| Placebo | 19 | 4 | - |
The number of patients who experienced an adverse event in the study is presented.
Population: All patients who entered the study, were randomised, received at least one dose of study medication and yielded on-treatment efficacy data were included in the safety analysis.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 | 36 | 35 | - |
| Placebo | 34 | 26 | - |
| Milestone | GW-1000-02 | Placebo |
|---|---|---|
| STARTED | 36 | 34 |
| COMPLETED | 32 | 31 |
| NOT COMPLETED | 4 | 3 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Sepsis Not Otherwise Specified | Infections and infestations | GW-1000-02: 0 / 36 · Placebo: 1 / 34 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Gamma-Glutamyltransferase Increased | Investigations | GW-1000-02: 0 / 36 · Placebo: 2 / 34 |
| Urinary Tract Infection Not Otherwise Specified | Infections and infestations | GW-1000-02: 4 / 36 · Placebo: 8 / 34 |
| Dizziness | Nervous system disorders | GW-1000-02: 20 / 36 · Placebo: 5 / 34 |
| Headache Not Otherwise Specified | Nervous system disorders | GW-1000-02: 4 / 36 · Placebo: 5 / 34 |
| Gait Abnormal Not Otherwise Specified | Nervous system disorders | GW-1000-02: 2 / 36 · Placebo: 0 / 34 |
| Somnolence | Nervous system disorders | GW-1000-02: 2 / 36 · Placebo: 0 / 34 |
| Nausea | Gastrointestinal disorders | GW-1000-02: 5 / 36 · Placebo: 2 / 34 |
| Dry Mouth | Gastrointestinal disorders | GW-1000-02: 4 / 36 · Placebo: 0 / 34 |
| Dysgeusia | Nervous system disorders | GW-1000-02: 0 / 36 · Placebo: 2 / 34 |
| Paraesthesia | Nervous system disorders | GW-1000-02: 0 / 36 · Placebo: 2 / 34 |
| Oral Discomfort | Gastrointestinal disorders | GW-1000-02: 2 / 36 · Placebo: 0 / 34 |
| Oral Pain | Gastrointestinal disorders | GW-1000-02: 2 / 36 · Placebo: 2 / 34 |
| Vomiting Not Otherwise Specified | Gastrointestinal disorders | GW-1000-02: 2 / 36 · Placebo: 0 / 34 |
| Diarrhoea Not Otherwise Specified | Gastrointestinal disorders | GW-1000-02: 0 / 36 · Placebo: 3 / 34 |
| Application Site Pain | General disorders | GW-1000-02: 4 / 36 · Placebo: 3 / 34 |
| Fatigue | General disorders | GW-1000-02: 4 / 36 · Placebo: 0 / 34 |
| Feeling Drunk | General disorders | GW-1000-02: 3 / 36 · Placebo: 0 / 34 |
| Application Site Burning | General disorders | GW-1000-02: 2 / 36 · Placebo: 0 / 34 |
| Feeling of Relaxation | General disorders | GW-1000-02: 2 / 36 · Placebo: 0 / 34 |
| Lethargy | General disorders | GW-1000-02: 2 / 36 · Placebo: 0 / 34 |
| Thirst | General disorders | GW-1000-02: 2 / 36 · Placebo: 0 / 34 |
| Weakness | General disorders | GW-1000-02: 2 / 36 · Placebo: 0 / 34 |
| Confusional State | Psychiatric disorders | GW-1000-02: 3 / 36 · Placebo: 0 / 34 |
| Euphoric Mood | Psychiatric disorders | GW-1000-02: 2 / 36 · Placebo: 0 / 34 |
| Paranoia | Psychiatric disorders | GW-1000-02: 2 / 36 · Placebo: 0 / 34 |
| Insomnia | Psychiatric disorders | GW-1000-02: 0 / 36 · Placebo: 3 / 34 |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | GW-1000-02: 2 / 36 · Placebo: 0 / 34 |
| Appetite Increased | Metabolism and nutrition disorders | GW-1000-02: 3 / 36 · Placebo: 0 / 34 |
| Vision Blurred | Eye disorders | GW-1000-02: 2 / 36 · Placebo: 0 / 34 |
| Pain in Limb | Musculoskeletal and connective tissue disorders | GW-1000-02: 0 / 36 · Placebo: 2 / 34 |
| Back Pain Aggravated | Musculoskeletal and connective tissue disorders | GW-1000-02: 0 / 36 · Placebo: 2 / 34 |
| Peripheral Swelling | Musculoskeletal and connective tissue disorders | GW-1000-02: 0 / 36 · Placebo: 2 / 34 |
| Hypertension Not Otherwise Specified | Vascular disorders | GW-1000-02: 0 / 36 · Placebo: 2 / 34 |
Time frame: 0 - 3 weeks
The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as "Very Much Improved", "Much Improved", "Minimally Improved", "No Change", "Minimally Worse", "Much Worse" and "Very Much Worse" and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being "Very Much Improved" or "Much Improved" is presented.
Time frame: 0 - 3 weeks
Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.
Time frame: 0 - 3 weeks
The percentage of days on treatment on which escape medication was used is presented.
Time frame: 0 - 3 weeks
Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as "No", "Once", "Twice", "More than twice" and "Awake most of the night"; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement.
Time frame: 0 - 3 weeks
The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero "no disability" to 10 "total disability" scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement.
Time frame: 0 - 3 weeks
The Brief Pain Inventory (Short Form) 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 reduction in score from baseline indicates an improvement.
Time frame: 0 - 3 weeks
The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.
Time frame: 0 - 3 weeks
The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as "Very Much Improved", "Much Improved", "Minimally Improved", "No Change", "Minimally Worse", "Much Worse" and "Very Much Worse" and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being "Very Much Improved" or "Much Improved" is presented.
Time frame: 0 - 65 days
The number of patients who experienced an adverse event in the study is presented.