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A Study of Sativex® for Relief of Peripheral Neuropathic Pain Associated With Allodynia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00711880
Recruitment Status : Completed
First Posted : July 9, 2008
Results First Posted : September 28, 2012
Last Update Posted : June 24, 2013
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Pain
Peripheral Neuropathy
Interventions Drug: Sativex®
Drug: Placebo
Enrollment 125
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sativex Placebo
Hide Arm/Group Description 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. Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Period Title: Overall Study
Started 63 62
Completed 50 55
Not Completed 13 7
Reason Not Completed
Adverse Event             11             2
Patient non-compliance             1             0
Lack of Efficacy             1             5
Arm/Group Title Sativex Placebo Total
Hide Arm/Group Description 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. Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours. Total of all reporting groups
Overall Number of Baseline Participants 63 62 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 62 participants 125 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
  81.0%
49
  79.0%
100
  80.0%
>=65 years
12
  19.0%
13
  21.0%
25
  20.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 62 participants 125 participants
52.4  (15.8) 54.3  (15.2) 53.4  (15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 62 participants 125 participants
Female
35
  55.6%
39
  62.9%
74
  59.2%
Male
28
  44.4%
23
  37.1%
51
  40.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 63 participants 62 participants 125 participants
United Kingdom 51 50 101
Belgium 12 12 24
1.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Day 0 to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 61 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.57  (2.11) -0.59  (1.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in Numerical Rating Scale Peripheral Neuropathic Pain scores was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale Peripheral Neuropathic Pain score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-1.59 to -0.32
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment
Hide Description 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.
Time Frame Day 0 to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 59 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.7  (19.35) -2.0  (12.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in Neuropathic Pain Scale scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Neuropathic Pain Scale score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -8.03
Confidence Interval (2-Sided) 95%
-13.83 to -2.23
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Mean Sleep Quality at the End of Treatment
Hide Description 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.
Time Frame Day 7 - Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 61 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.82  (0.76) -0.38  (0.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in sleep disturbance scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline sleep disturbance score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-0.67 to -0.19
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Mean Pain Disability Index Score at the End of Treatment
Hide Description 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.
Time Frame Day 0 - Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 53 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.6  (12.08) 0.3  (8.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in total Pain Disability Index scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total Pain Disability Index score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -5.85
Confidence Interval (2-Sided) 95%
-9.62 to -2.09
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Mean Dynamic Allodynia Test Score at the End of Treatment
Hide Description 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.
Time Frame Day 7 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 55 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.15  (2.23) -0.38  (1.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in Dynamic Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Dynamic Allodynia Test score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.82
Confidence Interval (2-Sided) 95%
-1.60 to -0.03
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Mean Static Allodynia Test Score at the End of Treatment
Hide Description 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.
Time Frame Day 0 - Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 56 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.22  (50.20) 2.84  (44.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in Static Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Static Allodynia Test score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.144
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 12.73
Confidence Interval (2-Sided) 95%
-4.40 to 29.85
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Mean Total General Health Questionnaire Score at the End of Treatment
Hide Description 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.
Time Frame Day 7 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 60 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.0  (7.93) -2.6  (5.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in total General Health Questionnaire score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total General Health Questionnaire score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.483
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.75
Confidence Interval (2-Sided) 95%
-2.84 to 1.35
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment
Hide Description 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.
Time Frame Day 7 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 40 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.53  (1.10) 0.48  (1.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in selective reminding test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline selective reminding test score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.924
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.46 to 0.50
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for ‘10/36 Spatial Recall' at the End of Treatment
Hide Description 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.
Time Frame Day 7 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 39 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.79  (2.01) 0.15  (2.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in 10/36 spatial recall test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline 10/36 spatial recall test score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
-0.31 to 1.38
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment
Hide Description 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.
Time Frame Day 7 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 39 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.6  (5.83) 3.9  (7.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in symbol digit modalities test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline symbol digit modalities test score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.158
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -2.15
Confidence Interval (2-Sided) 95%
-5.15 to 0.85
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Paced Auditory Serial Addition Task' at the End of Treatment
Hide Description 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
Time Frame Day 7 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 24 29
Mean (Standard Deviation)
Unit of Measure: percentage of correct answers
8.0  (14.23) 6.3  (9.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in paced auditory serial addition task score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline paced auditory serial addition task test score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.656
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
-4.47 to 7.04
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment
Hide Description 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).
Time Frame Day 7 and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 38 41
Mean (Standard Deviation)
Unit of Measure: number of words
3.5  (7.67) 3.5  (8.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in word list generation test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline word list generation test score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.962
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-3.56 to 3.39
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Subject Global Impression of Change in the Severity of Peripheral Neuropathic Pain at the End of Treatment
Hide Description 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.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Unit of Measure: participants
Very Much Worse 5 0
Much Improved 11 6
Minimally Improved 16 6
No Change 26 46
Minimally Worse 0 2
Much Worse 4 2
Very Much Worse 0 0
Missing 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The proportion of subjects who considered their condition ‘Very Much Improved’, ‘Much Improved’ or ‘Minimally Improved’ was compared between treatment groups for each question, using Fisher’s Exact Test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 32.26
Confidence Interval (2-Sided) 95%
16.40 to 48.12
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Pre-dose in Mean Intoxication 100 mm Visual Analogue Scale Score at the End of Treatment
Hide Description 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.
Time Frame Day 0 - Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 62 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.2  (11.39) 1.4  (10.74)
15.Secondary Outcome
Title Subject Global Impression of Change in the Severity of Allodynia in Their Chosen Allodynic Area at the End of Treatment
Hide Description

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

Time Frame Day 0 - 42
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Unit of Measure: participants
Very Much Improved 3 0
Much Improved 12 3
Minimally Improved 14 8
No Change 30 47
Minimally Worse 1 2
Much Worse 2 2
Very Much Worse 0 0
Missing 1 0
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Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The proportion of subjects who considered their condition ‘Very Much Improved’, ‘Much Improved’ or ‘Minimally Improved’ was compared between treatment groups for each question, using Fisher’s Exact Test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 29.03
Confidence Interval 95%
13.39 to 44.67
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Incidence of Adverse Events as a Measure of Subject Safety
Hide Description The number of subjects who reported an adverse event during the course of the study is presented
Time Frame Day 0 - Day 42
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Hide Analysis Population Description
All randomised subjects who received at least one dose of study medication and had on-treatment efficacy data were included in the analysis
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
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.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Unit of Measure: participants
57 48
Time Frame 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.
Adverse Event Reporting Description All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
 
Arm/Group Title Sativex Placebo
Hide Arm/Group Description 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. Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
All-Cause Mortality
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/63 (1.59%)   2/62 (3.23%) 
General disorders     
Fall  1  0/63 (0.00%)  1/62 (1.61%) 
Infections and infestations     
Bronchopneumonia  1  1/63 (1.59%)  0/62 (0.00%) 
Nervous system disorders     
Transient ischaemic attack  1  1/63 (1.59%)  0/62 (0.00%) 
Hypoaesthesia  1  0/63 (0.00%)  0/62 (0.00%) 
Myelitis NOS  1  0/63 (0.00%)  1/62 (1.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   57/63 (90.48%)   48/62 (77.42%) 
Eye disorders     
Vision Blurred  1  2/63 (3.17%)  0/62 (0.00%) 
Gastrointestinal disorders     
Nausea  1  14/63 (22.22%)  7/62 (11.29%) 
Dry Mouth  1  11/63 (17.46%)  3/62 (4.84%) 
Vomiting Not Otherwise Specified (NOS)  1  8/63 (12.70%)  3/62 (4.84%) 
Diarrhoea NOS  1  4/63 (6.35%)  0/62 (0.00%) 
Abdominal pain upper  1  3/63 (4.76%)  0/62 (0.00%) 
Oral Pain  1  0/63 (0.00%)  2/62 (3.23%) 
Dyspepsia  1  0/63 (0.00%)  2/62 (3.23%) 
Constipation  1  2/63 (3.17%)  4/62 (6.45%) 
General disorders     
Fatigue  1  13/63 (20.63%)  5/62 (8.06%) 
Feeling drunk  1  6/63 (9.52%)  0/62 (0.00%) 
Fall  1  0/63 (0.00%)  3/62 (4.84%) 
Lethargy  1  2/63 (3.17%)  0/62 (0.00%) 
Malaise  1  2/63 (3.17%)  0/62 (0.00%) 
Application Site Burning  1  2/63 (3.17%)  4/62 (6.45%) 
Application Site Pain  1  4/63 (6.35%)  2/62 (3.23%) 
Infections and infestations     
Nasopharyngitis  1  4/63 (6.35%)  2/62 (3.23%) 
Investigations     
Blood Glucose Increased  1  2/63 (3.17%)  0/62 (0.00%) 
Blood Alkaline Phosphatase NOS Increased  1  0/63 (0.00%)  2/62 (3.23%) 
Metabolism and nutrition disorders     
Anorexia  1  4/63 (6.35%)  0/62 (0.00%) 
Hunger  1  2/63 (3.17%)  0/62 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/63 (0.00%)  2/62 (3.23%) 
Nervous system disorders     
Dizziness  1  18/63 (28.57%)  9/62 (14.52%) 
Headache NOS  1  6/63 (9.52%)  9/62 (14.52%) 
Somnolence  1  4/63 (6.35%)  0/62 (0.00%) 
Disturbance in attention  1  3/63 (4.76%)  0/62 (0.00%) 
Memory impairment  1  3/63 (4.76%)  0/62 (0.00%) 
Hypoaesthesia  1  0/63 (0.00%)  3/62 (4.84%) 
Psychiatric disorders     
Agitation  1  2/63 (3.17%)  0/62 (0.00%) 
Euphoric Mood  1  2/63 (3.17%)  0/62 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  2/63 (3.17%)  0/62 (0.00%) 
Pharyngitis  1  2/63 (3.17%)  2/62 (3.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mr Richard Potts, Clinical Operations Director
Organization: GW Pharma Ltd
Phone: 0044 1223 266800
EMail: rp@gwpharm.com
Layout table for additonal information
Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00711880     History of Changes
Other Study ID Numbers: GWNP0101
First Submitted: July 7, 2008
First Posted: July 9, 2008
Results First Submitted: July 19, 2012
Results First Posted: September 28, 2012
Last Update Posted: June 24, 2013