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The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving peripheral neuropathic pain associated with allodynia.
This was a six week, multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy of Sativex®. Subjects with peripheral neuropathic pain characterised by allodynia, were screened to determine eligibility and entered a seven day baseline period. Subjects then returned to the centre for randomisation and dose introduction, and received either placebo or Sativex in a double blind manner for five weeks, with a follow up visit 7 to 10 days after the end of the treatment period. The primary efficacy measure was the difference in pain severity at the end of treatment, measured using a peripheral neuropathic pain 0 to 10 numerical rating scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sativex | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sativex® | Drug | containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Mean Daily Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale Score During the Last Seven Days of Treatment (End of Treatment) | The neuropathic pain Numerical Rating Scale 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 or average pain in the last 24 hours" where 0 = no pain and 10 = worst possible pain. A negative value indicates an improvement in pain score from baseline. | Day 0 to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment | The Neuropathic Pain Scale (NPS) score consisted of a series of assessments of different aspects of pain (intensity, sharpness, hot, dull, cold, sensitive, itchy, unpleasantness, and surface compared with deep), each scored using 11-point Numerical Rating Scales. 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Turo Nurmikko, MB BS PhD | Clinical Trials Unit, The Walton Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Unit, The Walton Centre | Fazakerley | Liverpool | L9 7LJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17997224 | Result | Nurmikko TJ, Serpell MG, Hoggart B, Toomey PJ, Morlion BJ, Haines D. Sativex successfully treats neuropathic pain characterised by allodynia: a randomised, double-blind, placebo-controlled clinical trial. Pain. 2007 Dec 15;133(1-3):210-20. doi: 10.1016/j.pain.2007.08.028. Epub 2007 Nov 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sativex | Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours. |
| FG001 | Placebo | Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sativex | Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Mean Daily Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale Score During the Last Seven Days of Treatment (End of Treatment) | The neuropathic pain Numerical Rating Scale 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 or average pain in the last 24 hours" where 0 = no pain and 10 = worst possible pain. A negative value indicates an improvement in pain score from baseline. | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Day 0 to Day 42 |
|
All adverse events occurring from the time of consent to post study follow up i.e.8 weeks were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sativex | Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml per 100 micro litre. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | MedDRA 5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr Richard Potts, Clinical Operations Director | GW Pharma Ltd | 0044 1223 266800 | rp@gwpharm.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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|
| Placebo | Drug | containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. |
|
|
| Day 0 to Day 42 |
| Change From Baseline in Mean Sleep Quality at the End of Treatment | 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. | Day 7 - Day 42 |
| Change From Baseline in the Mean Pain Disability Index Score at the End of Treatment | The Pain Disability Index consisted of seven self-administered questions relating to the effect of the subject's chronic pain on their personal life (family/home responsibilities, social activity, sexual behaviour, life-support activity, recreation, occupation and self-care). Each assessment was scored on an 11-point Numerical Rating Scale ranging from 0 (which equals 'no disability') to 10 (which equals 'total disability'). The total Pain Disability Index is the unweighted sum of the seven Numerical Rating Scale scores. The maximum (worst) total score was 70. | Day 0 - Day 42 |
| Change From Baseline in Mean Dynamic Allodynia Test Score at the End of Treatment | Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5sec intervals, and recording the pain severity on a 0-10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes. A negative change from baseline indicates an improvement in score. | Day 7 and Day 42 |
| Change From Baseline in Mean Static Allodynia Test Score at the End of Treatment | The static allodynia test involved applying pressure to a non-allodynic area (on the contralateral side to the identified allodynic area), and recording the pressure that caused pain to this area. Seventy five percent of the pressure that caused pain to the non-allodynic area (up to the subject's pain/pressure threshold) was then applied to the allodynic area, and an 11-point Numerical Rating Scale pain score recorded (between 0 (no pain)and 10 (most intense pain imaginable)). A negative value indicates an improvement in pain score from baseline. | Day 0 - Day 42 |
| Change From Baseline in Mean Total General Health Questionnaire Score at the End of Treatment | The General Health Questionnaire-12 is designed to measure non-psychotic mental disorders. It consists of 12 questions, scored on a 0 to 3 Likert scale to measure and compare psychological morbidity levels, where 0 represents better psychological health. The total General Health Questionnaire-12 score is the unweighted sum of the 12 scores. Zero indicates the best possible psychological health, 36 indicates the worst possible psychological health. | Day 7 and Day 42 |
| Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment | The Selective Reminding Test measures verbal learning and delayed recall through a multiple-trial list-learning paradigm. Patients are presented aurally with a list of 12 words for trial 1 and are asked to recall as many as possible. For trials 2-6, there is a selective presentation of only those words not recalled on the previous trial. Trial 7 is similar to the other trials but is assessed after an 11-minute delay. The score for the selective reminding test is the unweighted average of seven individual study results (min=0 and max=84) Higher scores indicate a better cognitive performance. | Day 7 and Day 42 |
| Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for '10/36 Spatial Recall' at the End of Treatment | The 10/36 Spatial Recall Test assesses visual spatial learning and delayed recall. Patients are asked to view a 6 x 6 checkerboard with ten checkers for 10 seconds. They are then asked to recreate the pattern viewed on a blank checkerboard. The number of correct responses from three immediate trials and one delayed trial (7 minute delay) are recorded. The Total number of correct responses is the unweighted sum from the four trials. The score for the 10/36 spatial recall test was the unweighted average of four individual study results (min=0 and max=40). A higher score indicates better cognitive performance. | Day 7 and Day 42 |
| Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment | The Symbol Digit Modalities Test measures complex attention and concentration in a task which also requires speed and accuracy in visual search and scanning. Patients are required to associate symbols with numbers and quickly generate the number when shown the symbol. The summary endpoint is the number of correct responses in 90 seconds. The symbol digit modalities test had a min of 0 and max score of 99. A higher score indicates better cognitive performance. | Day 7 and Day 42 |
| Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Paced Auditory Serial Addition Task' at the End of Treatment | The Paced Auditory Serial Addition Task assesses sustained attention and concentration. A pre-recorded tape is used to present two series of 60 numbers, one every 3 seconds and one every 2 seconds. Patients are asked to add each number to the one immediately preceding it and give the result. The task summary score is the percentage of correct answers is calculated. The PASAT score range was 0% to 100%. Higher scores indicate a better cognitive | Day 7 and Day 42 |
| Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment | Word list generation measures verbal associative fluency. Patients are given 60 seconds to give as many words beginning with a particular letter. The Total is the unweighted sum of all admissible words over three different trials. Higher scores indicate a better cognitive performance (min=0, max= not defined). | Day 7 and Day 42 |
| Subject Global Impression of Change in the Severity of Peripheral Neuropathic Pain at the End of Treatment | Subjects were asked to give their impression of the overall change in their peripheral neuropathic pain since entry into the study using the following seven-point scale: 1 = 'Very Much Improved', 2 = 'Much Improved', 3 = 'Minimally Improved', 4 = 'No Change', 5 = 'Minimally Worse', 6 = 'Much Worse', 7 = 'Very Much Worse'. The number of subjects who reported an improvement is presented. | Day 42 |
| Change From Pre-dose in Mean Intoxication 100 mm Visual Analogue Scale Score at the End of Treatment | Intoxication scores were measured using a 100 mm Visual Analogue Scale, where 0 equalled 'no intoxication' and 100 equalled 'extreme intoxication'. A negative value indicates an improvement in intoxication score from baseline. | Day 0 - Day 42 |
| Subject Global Impression of Change in the Severity of Allodynia in Their Chosen Allodynic Area at the End of Treatment | Subjects were asked to give their impression of the overall change in their allodynia since entry into the study using the following seven-point scale: 1 = 'Very Much Improved', 2 = 'Much Improved', 3 = 'Minimally Improved', 4 = 'No Change', 5 = 'Minimally Worse', 6 = 'Much Worse', 7 = 'Very Much Worse'. A summary of the number and percentage of subjects | Day 0 - 42 |
| Incidence of Adverse Events as a Measure of Subject Safety | The number of subjects who reported an adverse event during the course of the study is presented | Day 0 - Day 42 |
| Lack of Efficacy |
|
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours. |
|
|
|
| Secondary | Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment | The Neuropathic Pain Scale (NPS) score consisted of a series of assessments of different aspects of pain (intensity, sharpness, hot, dull, cold, sensitive, itchy, unpleasantness, and surface compared with deep), each scored using 11-point Numerical Rating Scales. 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. | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Day 0 to Day 42 |
|
|
|
|
| Secondary | Change From Baseline in Mean Sleep Quality at the End of Treatment | 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. | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Day 7 - Day 42 |
|
|
|
|
| Secondary | Change From Baseline in the Mean Pain Disability Index Score at the End of Treatment | The Pain Disability Index consisted of seven self-administered questions relating to the effect of the subject's chronic pain on their personal life (family/home responsibilities, social activity, sexual behaviour, life-support activity, recreation, occupation and self-care). Each assessment was scored on an 11-point Numerical Rating Scale ranging from 0 (which equals 'no disability') to 10 (which equals 'total disability'). The total Pain Disability Index is the unweighted sum of the seven Numerical Rating Scale scores. The maximum (worst) total score was 70. | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Day 42 |
|
|
|
|
| Secondary | Change From Baseline in Mean Dynamic Allodynia Test Score at the End of Treatment | Dynamic allodynia was assessed by stroking the skin over the affected area five times with a standardised brush, designed specifically for sensory testing at 5sec intervals, and recording the pain severity on a 0-10 point scale (0= no pain to 10 = most pain imaginable). All strokes were of the same length, minimum 2 cm. Each dynamic allodynia score was calculated as the average of the five strokes. A negative change from baseline indicates an improvement in score. | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Day 7 and Day 42 |
|
|
|
|
| Secondary | Change From Baseline in Mean Static Allodynia Test Score at the End of Treatment | The static allodynia test involved applying pressure to a non-allodynic area (on the contralateral side to the identified allodynic area), and recording the pressure that caused pain to this area. Seventy five percent of the pressure that caused pain to the non-allodynic area (up to the subject's pain/pressure threshold) was then applied to the allodynic area, and an 11-point Numerical Rating Scale pain score recorded (between 0 (no pain)and 10 (most intense pain imaginable)). A negative value indicates an improvement in pain score from baseline. | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Day 42 |
|
|
|
|
| Secondary | Change From Baseline in Mean Total General Health Questionnaire Score at the End of Treatment | The General Health Questionnaire-12 is designed to measure non-psychotic mental disorders. It consists of 12 questions, scored on a 0 to 3 Likert scale to measure and compare psychological morbidity levels, where 0 represents better psychological health. The total General Health Questionnaire-12 score is the unweighted sum of the 12 scores. Zero indicates the best possible psychological health, 36 indicates the worst possible psychological health. | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Day 7 and Day 42 |
|
|
|
|
| Secondary | Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment | The Selective Reminding Test measures verbal learning and delayed recall through a multiple-trial list-learning paradigm. Patients are presented aurally with a list of 12 words for trial 1 and are asked to recall as many as possible. For trials 2-6, there is a selective presentation of only those words not recalled on the previous trial. Trial 7 is similar to the other trials but is assessed after an 11-minute delay. The score for the selective reminding test is the unweighted average of seven individual study results (min=0 and max=84) Higher scores indicate a better cognitive performance. | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Day 7 and Day 42 |
|
|
|
|
| Secondary | Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for '10/36 Spatial Recall' at the End of Treatment | The 10/36 Spatial Recall Test assesses visual spatial learning and delayed recall. Patients are asked to view a 6 x 6 checkerboard with ten checkers for 10 seconds. They are then asked to recreate the pattern viewed on a blank checkerboard. The number of correct responses from three immediate trials and one delayed trial (7 minute delay) are recorded. The Total number of correct responses is the unweighted sum from the four trials. The score for the 10/36 spatial recall test was the unweighted average of four individual study results (min=0 and max=40). A higher score indicates better cognitive performance. | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Day 7 and Day 42 |
|
|
|
|
| Secondary | Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment | The Symbol Digit Modalities Test measures complex attention and concentration in a task which also requires speed and accuracy in visual search and scanning. Patients are required to associate symbols with numbers and quickly generate the number when shown the symbol. The summary endpoint is the number of correct responses in 90 seconds. The symbol digit modalities test had a min of 0 and max score of 99. A higher score indicates better cognitive performance. | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Day 7 and Day 42 |
|
|
|
|
| Secondary | Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Paced Auditory Serial Addition Task' at the End of Treatment | The Paced Auditory Serial Addition Task assesses sustained attention and concentration. A pre-recorded tape is used to present two series of 60 numbers, one every 3 seconds and one every 2 seconds. Patients are asked to add each number to the one immediately preceding it and give the result. The task summary score is the percentage of correct answers is calculated. The PASAT score range was 0% to 100%. Higher scores indicate a better cognitive | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Mean | Standard Deviation | percentage of correct answers | Day 7 and Day 42 |
|
|
|
|
| Secondary | Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment | Word list generation measures verbal associative fluency. Patients are given 60 seconds to give as many words beginning with a particular letter. The Total is the unweighted sum of all admissible words over three different trials. Higher scores indicate a better cognitive performance (min=0, max= not defined). | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Mean | Standard Deviation | number of words | Day 7 and Day 42 |
|
|
|
|
| Secondary | Subject Global Impression of Change in the Severity of Peripheral Neuropathic Pain at the End of Treatment | Subjects were asked to give their impression of the overall change in their peripheral neuropathic pain since entry into the study using the following seven-point scale: 1 = 'Very Much Improved', 2 = 'Much Improved', 3 = 'Minimally Improved', 4 = 'No Change', 5 = 'Minimally Worse', 6 = 'Much Worse', 7 = 'Very Much Worse'. The number of subjects who reported an improvement is presented. | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Number | participants | Day 42 |
|
|
|
|
| Secondary | Change From Pre-dose in Mean Intoxication 100 mm Visual Analogue Scale Score at the End of Treatment | Intoxication scores were measured using a 100 mm Visual Analogue Scale, where 0 equalled 'no intoxication' and 100 equalled 'extreme intoxication'. A negative value indicates an improvement in intoxication score from baseline. | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Day 0 - Day 42 |
|
|
|
| Secondary | Subject Global Impression of Change in the Severity of Allodynia in Their Chosen Allodynic Area at the End of Treatment | Subjects were asked to give their impression of the overall change in their allodynia since entry into the study using the following seven-point scale: 1 = 'Very Much Improved', 2 = 'Much Improved', 3 = 'Minimally Improved', 4 = 'No Change', 5 = 'Minimally Worse', 6 = 'Much Worse', 7 = 'Very Much Worse'. A summary of the number and percentage of subjects | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Number | participants | Day 0 - 42 |
|
|
|
|
| Secondary | Incidence of Adverse Events as a Measure of Subject Safety | The number of subjects who reported an adverse event during the course of the study is presented | All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis | Posted | Number | participants | Day 0 - Day 42 |
|
|
|
| 1 |
| 63 |
| 57 |
| 63 |
| EG001 | Placebo | Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours. | 2 | 62 | 48 | 62 |
| Bronchopneumonia | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Myelitis NOS | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Vomiting Not Otherwise Specified (NOS) | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Feeling drunk | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Headache NOS | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 5.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 5.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Fall | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 5.0 | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA 5.0 | Systematic Assessment |
|
| Oral Pain | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Lethargy | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Blood Glucose Increased | Investigations | MedDRA 5.0 | Systematic Assessment |
|
| Blood Alkaline Phosphatase NOS Increased | Investigations | MedDRA 5.0 | Systematic Assessment |
|
| Hunger | Metabolism and nutrition disorders | MedDRA 5.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 5.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
|
| Euphoric Mood | Psychiatric disorders | MedDRA 5.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 5.0 | Systematic Assessment |
|
| Application Site Burning | General disorders | MedDRA 5.0 | Systematic Assessment |
|
| Application Site Pain | General disorders | MedDRA 5.0 | Systematic Assessment |
|
GW will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications, for example manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.
| D009422 | Nervous System Diseases |
| Minimally Improved |
|
| No Change |
|
| Minimally Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Missing |
|
| Minimally Improved |
|
| No Change |
|
| Minimally Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Missing |
|