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An open-label extension study in which patients with multiple sclerosis received GW-1000-02 \[named Sativex® in Canada and also named Sativex® Oromucosal Spray\] for four weeks in an open-label manner.
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
Subjects who took part in GWMS0001 Part A were invited to continue to receive GW-1000-02 in this four-week open-label part of the study. Subjects received open-label cannabinoid extract (GW-1000-02) for four weeks, either with or without peppermint flavouring, according to their study centre. Subjects who completed the study could choose to continue receiving GW-1000-02 by entering the long-term safety extension follow-on study.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. The maximum permitted dose of study medication was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
SativexSource-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
This was achieved by measuring the change in the Part A study score (mean of all scores during the last two weeks of six weeks of double-blind therapy) in the severity of the primary impairment (mean of all scores during the last two weeks of four weeks of open-label therapy), a composite score from one of five multiple sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. As such, a decrease in score indicates an improvement and a negative value indicates an improvement in score from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 75 | -5.41 | 24.20 |
| Placebo DB/GW-1000-02 OL | 73 | -7.51 | 24.75 |
Eligibility
primary outcomes
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the Part A study score (mean of all scores during the last two weeks of six weeks of double-blind therapy) in the severity of the primary impairment (mean of all scores during the last two weeks of four weeks of open-label therapy), a composite score from one of five multiple sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. As such, a decrease in score indicates an improvement and a negative value indicates an improvement in score from baseline.
secondary outcomes
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy's Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Caregiver Strain Index is a 13-item questionnaire designed to detect strain in those that care for subjects. Carers were asked if they found certain situations difficult (i.e. work adjustments, family adjustment, emotional adjustments, physical effort). Each question was scored zero (answered no) or one (answered yes), and was recorded for each of the 13 questions. The summary parameter was the total score, which was the sum score of the 13 questions, giving a minimum possible score of 0 (no strain) and maximum possible score of 13 (maximum possible strain). As such a negative value from baseline indicates an improvement in caregiver strain.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Assessment of reading visual acuity was made using a standard reading chart. Scores could range from 1 (good) to 20 (bad), indicating good and poor eyesight, respectively. As such, a negative value from baseline indicates an improvement in eyesight.
Publications
No exact PMID-linked public article is currently readable locally.
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy's Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 61 | -1.8 | 4.93 |
| Placebo DB/GW-1000-02 OL | 56 | 0.5 | 5.35 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Caregiver Strain Index is a 13-item questionnaire designed to detect strain in those that care for subjects. Carers were asked if they found certain situations difficult (i.e. work adjustments, family adjustment, emotional adjustments, physical effort). Each question was scored zero (answered no) or one (answered yes), and was recorded for each of the 13 questions. The summary parameter was the total score, which was the sum score of the 13 questions, giving a minimum possible score of 0 (no strain) and maximum possible score of 13 (maximum possible strain). As such a negative value from baseline indicates an improvement in caregiver strain.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 21 | 0.5 | 2.40 |
| Placebo DB/GW-1000-02 OL | 14 | -0.1 | 1.77 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Assessment of reading visual acuity was made using a standard reading chart. Scores could range from 1 (good) to 20 (bad), indicating good and poor eyesight, respectively. As such, a negative value from baseline indicates an improvement in eyesight.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 73 | 0.4 | 1.95 |
| Placebo DB/GW-1000-02 OL | 71 | 0.1 | 2.42 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition. As such, a negative value indicates an improvement in score from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 72 | -0.54 | 1.98 |
| Placebo DB/GW-1000-02 OL | 72 | -0.02 | 1.72 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Short Orientation-Memory-Concentration test is a questionnaire designed to measure orientation, concentration on simple tasks and learning and recall of simple information. The test consists of six items, such as 'what year is it now?' and 'count backwards from 20 to 1'. Each item was scored between 0 (maximum number of errors) and three-10 (best score; no errors), with a point deducted for each error. The summary parameter was the total score from the sum of scores for each item, with an overall possible maximum score of 28 (no errors). Scores over 20 are considered 'normal'. As such, an increased score indicates an improvement, and a positive value indicates an improvement in score from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 76 | -0.0 | 4.25 |
| Placebo DB/GW-1000-02 OL | 75 | -0.5 | 3.86 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The ability to undertake the different daily activities was assessed on scales of 0-1 to 3, with 0= poorest outcome and upper scores= best outcome. The total score was the sum of scores for each item; minimum score= 0, maximum score= 20. A change of two or greater in the total score indicating a clinically relevant change. A positive value indicates an improvement in score from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 76 | 0.6 | 1.72 |
| Placebo DB/GW-1000-02 OL | 76 | 0.1 | 1.76 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Adult Memory and Information Processing Battery test comprises six sub-sections which assess cognition and mental alertness. These include immediate and delayed story recall, word-list learning, copying a complex figure followed by its immediate reproduction, design learning, and information processing (parts A and B). The sum score for each section gave the total score which ranged from 1 (bad) to 105 (good). As such, a positive value indicates an improvement in score from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 71 | 2.0 | 4.73 |
| Placebo DB/GW-1000-02 OL | 66 | 0.1 | 5.23 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The BDI-II was a 21-question multiple choice self-reported inventory. Subjects' responses to the 21 questions were assigned a score ranging from zero (good) to three (bad), indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. A decrease in score indicates an improvement in condition. As such, a negative value indicates in improvement in score from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 75 | -0.5 | 6.02 |
| Placebo DB/GW-1000-02 OL | 76 | -0.8 | 7.03 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Fatigue Severity Scale is a nine-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 0-6 scale (0= no fatigue and 6= severe fatigue). As such a decreased score indicates improvement, and a negative value indicates and improvement from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 75 | -0.25 | 0.96 |
| Placebo DB/GW-1000-02 OL | 75 | -0.15 | 0.95 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Rivermead Mobility Index is a measure of subject self-mobilisation and was developed to enable rehabilitation professionals to document the effect(s) of interventions. This consisted of 15 questions relating to the dexterity and/or mobility of the patient. Each question had a 'yes' / 'no' answer which was scored as yes=1 no=0. The summary parameter was the total for the 15 questions, with a maximum score of 15. An increased score indicates improvement. As such, a positive value indicates an improvement in score from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 76 | -0.1 | 1.77 |
| Placebo DB/GW-1000-02 OL | 76 | 0.2 | 1.89 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 28-item General Health Questionnaire is a self-reported questionnaire for the detection of non-psychotic mental disorders (anxiety and depression) in the community and primary care settings. A series of four subscale scores (ranging from 0 \[good\] to 21 \[bad\]) were combined to give a total score, which ranged from 0 (good) to 84 (bad). As such, a negative value indicates an improvement in score from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 76 | 0.2 | 10.08 |
| Placebo DB/GW-1000-02 OL | 74 | -0.6 | 10.60 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Nine-Hole Peg Test is a board with nine holes into which subjects have to insert nine pegs and is designed to test dexterity and coordination. Scores range from 0 (good) to 60 (bad). As such a decrease in score indicates an improvement, and a negative value indicates an improvement from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 63 | -0.74 | 3.81 |
| Placebo DB/GW-1000-02 OL | 65 | -0.20 | 1.63 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The total bladder control test score was the sum score from fifteen questions, which were each scored on a 0-2 scale (one question 0-3), where 0 = good and 2/3 = bad. Ten questions were related to bladder symptoms and control and five were related to the effects on the patient's life. The summary parameters were the total score with a minumum possible score of 0 and a maximum possible score of 31. A decrease in score indicates an improvement, as such a negative value indicates an improvement in condition from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 56 | -1.3 | 4.55 |
| Placebo DB/GW-1000-02 OL | 58 | -1.7 | 4.64 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The tremor activities of daily living scale is a patient self-reported questionnaire which consists of 25 questions relating to the effect of tremors on different day-to-day activities, such as eating, drinking, threading a needle and tying a shoe. The ability to perform these tasks was scored on a scale of 0 (unable) to 3 (completely able). The summary parameter was the total score with a minimum of 0 (unable to perform tasks) and a maximum of 75 (completely able to perform tasks). As such, a positive value indicates an improvement in condition from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 40 | -1.6 | 5.24 |
| Placebo DB/GW-1000-02 OL | 41 | 0.6 | 6.21 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep quality scores were rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 74 | -3.04 | 20.13 |
| Placebo DB/GW-1000-02 OL | 75 | -10.35 | 30.28 |
The number of patients who recorded an adverse event during the 4 week open-label period is presented.
Population: This analyses set included all patients who took GW-1000-02 during the open-label treatment period.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 77 | 41 | - |
| Placebo DB/GW-1000-02 OL | 77 | 54 | - |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 74 | -3.32 | 23.78 |
| Placebo DB/GW-1000-02 OL | 75 | -9.61 | 28.98 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Feeling upon wakening was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 74 | -8.49 | 24.78 |
| Placebo DB/GW-1000-02 OL | 75 | -7.01 | 27.52 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement, as such a negative value indicates an imrovement in condition from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 67 | -5.18 | 24.03 |
| Placebo DB/GW-1000-02 OL | 62 | -8.84 | 23.70 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in pain from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 39 | -11.56 | 21.40 |
| Placebo DB/GW-1000-02 OL | 45 | -12.51 | 24.81 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates and improvement in spasms from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 47 | -2.17 | 24.18 |
| Placebo DB/GW-1000-02 OL | 54 | -9.15 | 24.48 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in tremor from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 25 | -4.28 | 22.81 |
| Placebo DB/GW-1000-02 OL | 23 | -9.39 | 25.71 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in bladder problems from baseline.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 51 | -1.27 | 23.92 |
| Placebo DB/GW-1000-02 OL | 53 | -10.08 | 24.37 |
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 10 Metre Mobility Score is a four point scale assessing a subject's level of mobility. The time taken to walk ten metres was measured for the subset of subjects who were able to walk. A decrease in time indicates and improvement.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 38 | 1.87 | 10.12 |
| Placebo DB/GW-1000-02 OL | 47 | 2.40 | 9.58 |
A 7-point Likert-type scale was used, with the question: 'Please assess the status of your 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". The number of subjects that considered their condition to be better or much better at the end of open-label treatment is presented.
Population: All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| GW-1000-02 DB/OL | 76 | 53 | - |
| Placebo DB/GW-1000-02 OL | 76 | 44 | - |
| Milestone | GW-1000-02 DB/OL | Placebo DB/GW-1000-02 OL |
|---|---|---|
| STARTED | 77 | 77 |
| COMPLETED | 71 | 76 |
| NOT COMPLETED | 6 | 1 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | GW-1000-02 DB/OL: 1 / 77 · Placebo DB/GW-1000-02 OL: 0 / 77 |
| TRANSAMINASES INCREASED | Investigations | GW-1000-02 DB/OL: 1 / 77 · Placebo DB/GW-1000-02 OL: 0 / 77 |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | GW-1000-02 DB/OL: 1 / 77 · Placebo DB/GW-1000-02 OL: 0 / 77 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Nausea | Gastrointestinal disorders | GW-1000-02 DB/OL: 6 / 77 · Placebo DB/GW-1000-02 OL: 0 / 77 |
| Diarrhoea not otherwise specified | Gastrointestinal disorders | GW-1000-02 DB/OL: 4 / 77 · Placebo DB/GW-1000-02 OL: 2 / 77 |
| Dizziness | Nervous system disorders | GW-1000-02 DB/OL: 9 / 77 · Placebo DB/GW-1000-02 OL: 21 / 77 |
| Headache not otherwise specified | Nervous system disorders | GW-1000-02 DB/OL: 4 / 77 · Placebo DB/GW-1000-02 OL: 4 / 77 |
| Fatigue | General disorders | GW-1000-02 DB/OL: 0 / 77 · Placebo DB/GW-1000-02 OL: 4 / 77 |
| Vomiting Not Otherwise Specified | Gastrointestinal disorders | GW-1000-02 DB/OL: 3 / 77 · Placebo DB/GW-1000-02 OL: 0 / 77 |
| Dysgeusia | Nervous system disorders | GW-1000-02 DB/OL: 0 / 77 · Placebo DB/GW-1000-02 OL: 3 / 77 |
| Somnolence | Nervous system disorders | GW-1000-02 DB/OL: 2 / 77 · Placebo DB/GW-1000-02 OL: 3 / 77 |
| Nasopharyngitis | Infections and infestations | GW-1000-02 DB/OL: 0 / 77 · Placebo DB/GW-1000-02 OL: 3 / 77 |
| Weakness | General disorders | GW-1000-02 DB/OL: 0 / 77 · Placebo DB/GW-1000-02 OL: 3 / 77 |
| Feeling Abnormal | General disorders | GW-1000-02 DB/OL: 0 / 77 · Placebo DB/GW-1000-02 OL: 3 / 77 |
| Dry Mouth | Gastrointestinal disorders | GW-1000-02 DB/OL: 2 / 77 · Placebo DB/GW-1000-02 OL: 2 / 77 |
| Dyspepsia | Gastrointestinal disorders | GW-1000-02 DB/OL: 2 / 77 · Placebo DB/GW-1000-02 OL: 0 / 77 |
| Oral Discomfort | Gastrointestinal disorders | GW-1000-02 DB/OL: 2 / 77 · Placebo DB/GW-1000-02 OL: 2 / 77 |
| Oral Pain | Gastrointestinal disorders | GW-1000-02 DB/OL: 0 / 77 · Placebo DB/GW-1000-02 OL: 2 / 77 |
| Disturbance in Attention | Nervous system disorders | GW-1000-02 DB/OL: 2 / 77 · Placebo DB/GW-1000-02 OL: 2 / 77 |
| Balance Impaired Not Otherwise Specified | Nervous system disorders | GW-1000-02 DB/OL: 0 / 77 · Placebo DB/GW-1000-02 OL: 2 / 77 |
| Dysarthria | Nervous system disorders | GW-1000-02 DB/OL: 0 / 77 · Placebo DB/GW-1000-02 OL: 2 / 77 |
| Hypotonia | Nervous system disorders | GW-1000-02 DB/OL: 0 / 77 · Placebo DB/GW-1000-02 OL: 2 / 77 |
| Feeling Hot and Cold | General disorders | GW-1000-02 DB/OL: 2 / 77 · Placebo DB/GW-1000-02 OL: 0 / 77 |
| Malaise | General disorders | GW-1000-02 DB/OL: 2 / 77 · Placebo DB/GW-1000-02 OL: 0 / 77 |
| Application Site Pain | General disorders | GW-1000-02 DB/OL: 0 / 77 · Placebo DB/GW-1000-02 OL: 2 / 77 |
| Feeling Drunk | General disorders | GW-1000-02 DB/OL: 0 / 77 · Placebo DB/GW-1000-02 OL: 2 / 77 |
| Gamma-Glutamyltransferase Increased | Investigations | GW-1000-02 DB/OL: 2 / 77 · Placebo DB/GW-1000-02 OL: 0 / 77 |
| Vertigo | Ear and labyrinth disorders | GW-1000-02 DB/OL: 2 / 77 · Placebo DB/GW-1000-02 OL: 2 / 77 |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | GW-1000-02 DB/OL: 0 / 77 · Placebo DB/GW-1000-02 OL: 2 / 77 |
| Hypotension Not Otherwise Specified | Vascular disorders | GW-1000-02 DB/OL: 0 / 77 · Placebo DB/GW-1000-02 OL: 2 / 77 |
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition. As such, a negative value indicates an improvement in score from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Short Orientation-Memory-Concentration test is a questionnaire designed to measure orientation, concentration on simple tasks and learning and recall of simple information. The test consists of six items, such as 'what year is it now?' and 'count backwards from 20 to 1'. Each item was scored between 0 (maximum number of errors) and three-10 (best score; no errors), with a point deducted for each error. The summary parameter was the total score from the sum of scores for each item, with an overall possible maximum score of 28 (no errors). Scores over 20 are considered 'normal'. As such, an increased score indicates an improvement, and a positive value indicates an improvement in score from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The ability to undertake the different daily activities was assessed on scales of 0-1 to 3, with 0= poorest outcome and upper scores= best outcome. The total score was the sum of scores for each item; minimum score= 0, maximum score= 20. A change of two or greater in the total score indicating a clinically relevant change. A positive value indicates an improvement in score from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Adult Memory and Information Processing Battery test comprises six sub-sections which assess cognition and mental alertness. These include immediate and delayed story recall, word-list learning, copying a complex figure followed by its immediate reproduction, design learning, and information processing (parts A and B). The sum score for each section gave the total score which ranged from 1 (bad) to 105 (good). As such, a positive value indicates an improvement in score from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The BDI-II was a 21-question multiple choice self-reported inventory. Subjects' responses to the 21 questions were assigned a score ranging from zero (good) to three (bad), indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. A decrease in score indicates an improvement in condition. As such, a negative value indicates in improvement in score from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Fatigue Severity Scale is a nine-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 0-6 scale (0= no fatigue and 6= severe fatigue). As such a decreased score indicates improvement, and a negative value indicates and improvement from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Rivermead Mobility Index is a measure of subject self-mobilisation and was developed to enable rehabilitation professionals to document the effect(s) of interventions. This consisted of 15 questions relating to the dexterity and/or mobility of the patient. Each question had a 'yes' / 'no' answer which was scored as yes=1 no=0. The summary parameter was the total for the 15 questions, with a maximum score of 15. An increased score indicates improvement. As such, a positive value indicates an improvement in score from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 28-item General Health Questionnaire is a self-reported questionnaire for the detection of non-psychotic mental disorders (anxiety and depression) in the community and primary care settings. A series of four subscale scores (ranging from 0 \[good\] to 21 \[bad\]) were combined to give a total score, which ranged from 0 (good) to 84 (bad). As such, a negative value indicates an improvement in score from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Nine-Hole Peg Test is a board with nine holes into which subjects have to insert nine pegs and is designed to test dexterity and coordination. Scores range from 0 (good) to 60 (bad). As such a decrease in score indicates an improvement, and a negative value indicates an improvement from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The total bladder control test score was the sum score from fifteen questions, which were each scored on a 0-2 scale (one question 0-3), where 0 = good and 2/3 = bad. Ten questions were related to bladder symptoms and control and five were related to the effects on the patient's life. The summary parameters were the total score with a minumum possible score of 0 and a maximum possible score of 31. A decrease in score indicates an improvement, as such a negative value indicates an improvement in condition from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The tremor activities of daily living scale is a patient self-reported questionnaire which consists of 25 questions relating to the effect of tremors on different day-to-day activities, such as eating, drinking, threading a needle and tying a shoe. The ability to perform these tasks was scored on a scale of 0 (unable) to 3 (completely able). The summary parameter was the total score with a minimum of 0 (unable to perform tasks) and a maximum of 75 (completely able to perform tasks). As such, a positive value indicates an improvement in condition from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep quality scores were rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
The number of patients who recorded an adverse event during the 4 week open-label period is presented.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Feeling upon wakening was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement, as such a negative value indicates an imrovement in condition from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in pain from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates and improvement in spasms from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in tremor from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in bladder problems from baseline.
Time frame: End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 10 Metre Mobility Score is a four point scale assessing a subject's level of mobility. The time taken to walk ten metres was measured for the subset of subjects who were able to walk. A decrease in time indicates and improvement.
Time frame: End of Part B (week 10)
A 7-point Likert-type scale was used, with the question: 'Please assess the status of your 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". The number of subjects that considered their condition to be better or much better at the end of open-label treatment is presented.