Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

A Study of Sativex® for Pain 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: NCT00710554
Recruitment Status : Completed
First Posted : July 4, 2008
Results First Posted : September 14, 2012
Last Update Posted : February 13, 2014
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 246
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sativex Placebo
Hide Arm/Group Description Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period. Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
Period Title: Overall Study
Started 128 118
Completed 79 94
Not Completed 49 24
Reason Not Completed
Adverse Event             24             7
Withdrawal by Subject             7             3
Lost to Follow-up             7             1
Lack of Efficacy             11             12
Receiving radiotherapy - prostate cancer             0             1
Arm/Group Title Sativex Placebo Total
Hide Arm/Group Description Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period. Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period. Total of all reporting groups
Overall Number of Baseline Participants 128 118 246
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 118 participants 246 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
91
  71.1%
88
  74.6%
179
  72.8%
>=65 years
37
  28.9%
30
  25.4%
67
  27.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 118 participants 246 participants
57.6  (14.38) 57  (14.07) 57.3  (14.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 118 participants 246 participants
Female
85
  66.4%
65
  55.1%
150
  61.0%
Male
43
  33.6%
53
  44.9%
96
  39.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 128 participants 118 participants 246 participants
United Kingdom 74 72 146
Belgium 8 7 15
Canada 3 2 5
Czech Republic 35 32 67
Romania 8 5 13
1.Primary Outcome
Title Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks)
Hide Description The peripheral neuropathic pain NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline.
Time Frame Day 7 to Day 98
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses were conducted on data from all subjects who were randomised, received at least one dose of study medication and yielded on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
Overall Number of Participants Analyzed 77 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.36  (2.02) -0.84  (1.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. Due to the low power of the test for interaction, the test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.139
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter estimated mean treatment difference
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-0.79 to 0.11
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks)
Hide Description 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 7 to Day 98
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
Overall Number of Participants Analyzed 78 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.57  (16.15) -7.19  (19.65)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change from baseline in mean Neuropathic Pain Scale score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.198
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -2.86
Confidence Interval (2-Sided) 95%
-7.22 to 1.50
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks)
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 to Day 98
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
Overall Number of Participants Analyzed 81 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.0  (2.70) -1.2  (2.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change from baseline score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage 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 -0.83
Confidence Interval (2-Sided) 95%
-1.43 to -0.23
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks)
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 5 s 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 98
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
Overall Number of Participants Analyzed 112 102
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.1  (2.16) -1.0  (2.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in the dynamic allodynia pain score from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.795
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%
-0.52 to 0.68
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks)
Hide Description Punctate allodynia was measured using an in-house built pressure algometer comprising a strain gauge connected to a metal filament with a diameter of 1 mm and blunt tip at baseline and end of study. The filament was manually directed against the skin at an angle of 90 degrees and a steadily increasing pressure applied until the patient verbally indicated that they perceived pain (punctate pressure pain threshold). Patients were asked to verbally rate the intensity of the pain elicited, choosing a number between 0 (no pain)and 10 (most intense pain imaginable).
Time Frame Day 7 and Day 98
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
Overall Number of Participants Analyzed 112 106
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (0.78) 0.3  (1.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in the punctate allodynia pain threshold force from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.233
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.37 to 0.09
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Subject Global Impression of Change
Hide Description A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to peripheral neuropathy since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". At Visit 2 (Baseline) patients wrote a brief description of their pain caused by peripheral neuropathy which was used at end of treatment to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.
Time Frame Day 98
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
Overall Number of Participants Analyzed 117 111
Measure Type: Number
Unit of Measure: participants
Very much improved 8 4
Much improved 16 10
Slightly improved 38 24
No change 44 66
Slightly worse 9 4
Much worse 2 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The two treatment groups were compared using ordinal logistic regression and the proportional odds model. The initial model incorporated treatment and centre group as factors. The odds ratio together with its 95% CI and associated p-value are presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.762
Confidence Interval (2-Sided) 95%
1.08 to 2.88
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory (Short Form) Scores at the End of Treatment
Hide Description The BPI-SF is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.
Time Frame Day 7 and Day 98
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
Overall Number of Participants Analyzed 114 105
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.9  (1.69) -0.6  (1.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change from baseline in mean Brief Pain Inventory (short form) score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.288
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.72 to 0.21
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Quality of Life EuroQol 5-D (Health Status Index) Score at the End of Treatment (15 Weeks)
Hide Description The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.
Time Frame Day 7 and Day 98
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
Overall Number of Participants Analyzed 113 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.037  (0.187) 0.044  (0.214)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.617
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.06 to 0.04
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Quality of Life EuroQol 5-D (Health Status Visual Analogue Scale) Score at the End of Treatment (15 Weeks)
Hide Description The EQ-5D questionnaire provided two outcomes:(1)A weighted health state index visual analogue scale (VAS); (2) A self-rated health status VAS. EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.
Time Frame Day 7 and Day 98
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
Overall Number of Participants Analyzed 111 105
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.7  (20.6) 2.5  (21.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.75
Confidence Interval (2-Sided) 95%
-5.60 to 4.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.459
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in the Use of Rescue Analgesia at the End Treatment (15 Weeks)
Hide Description Use of break through medication was recorded daily during the study as the number of paracetamol tablets taken. The change in mean daily quantities of tablets used was calculated from baseline to the last seven days of treatment.
Time Frame Days 0-7 and Days 92-98
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for the analysis of efficacy was the full analysis set, which included all randomised subjects who received at least one dose of test treatment and had on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
Overall Number of Participants Analyzed 77 92
Mean (Standard Deviation)
Unit of Measure: number of tablets
-0.99  (2.20) -0.47  (2.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The model used for the analysis of the end of study value was an ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The null hypothesis was one of no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.112
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-0.85 to 0.09
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Incidence of Adverse Events as a Measure of Subject's Safety.
Hide Description The number of subjects that reported an adverse event in this study is presented.
Time Frame 19 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were included in this analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period.
Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
Overall Number of Participants Analyzed 128 118
Measure Type: Number
Unit of Measure: participants
109 83
Time Frame All adverse events occurring from the time of consent to post study follow up i.e. 19 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 Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg) up to a maximum of 24 actuations in any 24 hour period. Each 100 ul actuation delivered the excipients plus colorants, up to a maximum of 24 actuations in any 24 hour period.
All-Cause Mortality
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   10/128 (7.81%)   6/118 (5.08%) 
Cardiac disorders     
Myocardial Infarction  1  1/128 (0.78%)  0/118 (0.00%) 
Gastrointestinal disorders     
Inguinal Hernia  1  1/128 (0.78%)  0/118 (0.00%) 
Enterovesical Fistula  1  0/128 (0.00%)  1/118 (0.85%) 
General disorders     
Chest Pain  1  1/128 (0.78%)  0/118 (0.00%) 
Infections and infestations     
Bronchopneumonia  1  1/128 (0.78%)  0/118 (0.00%) 
Infective Exacerbation of Chronic Obstructive Airway Disease  1  1/128 (0.78%)  0/118 (0.00%) 
Pneumonia  1  1/128 (0.78%)  0/118 (0.00%) 
Subcutaneous Abscess  1  1/128 (0.78%)  0/118 (0.00%) 
Urinary Tract Infection  1  1/128 (0.78%)  0/118 (0.00%) 
Injury, poisoning and procedural complications     
Head Injury  1  0/128 (0.00%)  1/118 (0.85%) 
Joint Dislocation  1  0/128 (0.00%)  1/118 (0.85%) 
Lumbar Vertebral fracture  1  0/128 (0.00%)  1/118 (0.85%) 
Road Traffic Accident  1  0/128 (0.00%)  1/118 (0.85%) 
Soft Tissue Injury  1  0/128 (0.00%)  1/118 (0.85%) 
Musculoskeletal and connective tissue disorders     
Groin Pain  1  0/128 (0.00%)  1/118 (0.85%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer Stage II  1  1/128 (0.78%)  0/118 (0.00%) 
Malignant Melanoma  1  1/128 (0.78%)  0/118 (0.00%) 
Neoplasm Malignant  1  1/128 (0.78%)  0/118 (0.00%) 
Nervous system disorders     
Transient Ischaemic Attack  1  1/128 (0.78%)  0/118 (0.00%) 
Coma  1  0/128 (0.00%)  1/118 (0.85%) 
Dizziness  1  0/128 (0.00%)  1/118 (0.85%) 
Loss of Consciousness  1  0/128 (0.00%)  1/118 (0.85%) 
Vascular disorders     
Deep Vein Thrombosis  1  0/128 (0.00%)  1/118 (0.85%) 
Hypotension  1  0/128 (0.00%)  1/118 (0.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   109/128 (85.16%)   83/118 (70.34%) 
Ear and labyrinth disorders     
Vertigo  1  5/128 (3.91%)  0/118 (0.00%) 
Gastrointestinal disorders     
Nausea  1  23/128 (17.97%)  14/118 (11.86%) 
Vomiting  1  13/128 (10.16%)  7/118 (5.93%) 
Diarrhoea  1  12/128 (9.38%)  6/118 (5.08%) 
Dry Mouth  1  11/128 (8.59%)  4/118 (3.39%) 
Abdominal Pain Upper  1  6/128 (4.69%)  1/118 (0.85%) 
Dyspepsia  1  6/128 (4.69%)  4/118 (3.39%) 
Constipation  1  4/128 (3.13%)  2/118 (1.69%) 
Mouth Ulceration  1  4/128 (3.13%)  6/118 (5.08%) 
Oral Pain  1  4/128 (3.13%)  3/118 (2.54%) 
General disorders     
Fatigue  1  20/128 (15.63%)  8/118 (6.78%) 
Feeling Drunk  1  8/128 (6.25%)  3/118 (2.54%) 
Application Site Pain  1  7/128 (5.47%)  2/118 (1.69%) 
Infections and infestations     
Nasopharyngitis  1  9/128 (7.03%)  8/118 (6.78%) 
Gastroenteritis  1  4/128 (3.13%)  1/118 (0.85%) 
Lower Respiratory Tract Infection  1  4/128 (3.13%)  3/118 (2.54%) 
Metabolism and nutrition disorders     
Increased Appetite  1  6/128 (4.69%)  1/118 (0.85%) 
Anorexia  1  4/128 (3.13%)  1/118 (0.85%) 
Nervous system disorders     
Dizziness  1  52/128 (40.63%)  12/118 (10.17%) 
Dysgeusia  1  14/128 (10.94%)  2/118 (1.69%) 
Headache  1  13/128 (10.16%)  9/118 (7.63%) 
Disturbance in Attention  1  8/128 (6.25%)  2/118 (1.69%) 
Neuropathy Peripheral  1  6/128 (4.69%)  4/118 (3.39%) 
Tremor  1  6/128 (4.69%)  0/118 (0.00%) 
Somnolence  1  5/128 (3.91%)  2/118 (1.69%) 
Balance Disorder  1  4/128 (3.13%)  2/118 (1.69%) 
Memory Impairment  1  4/128 (3.13%)  2/118 (1.69%) 
Sedation  1  4/128 (3.13%)  0/118 (0.00%) 
Psychiatric disorders     
Dissociation  1  9/128 (7.03%)  0/118 (0.00%) 
Disorientation  1  8/128 (6.25%)  0/118 (0.00%) 
Depression  1  6/128 (4.69%)  0/118 (0.00%) 
Anxiety  1  4/128 (3.13%)  1/118 (0.85%) 
Panic Attack  1  4/128 (3.13%)  1/118 (0.85%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal Pain  1  7/128 (5.47%)  5/118 (4.24%) 
Dyspnoea  1  4/128 (3.13%)  3/118 (2.54%) 
Skin and subcutaneous tissue disorders     
Rash  1  5/128 (3.91%)  4/118 (3.39%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
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: NCT00710554    
Other Study ID Numbers: GWCL0405
First Submitted: July 3, 2008
First Posted: July 4, 2008
Results First Submitted: July 11, 2012
Results First Posted: September 14, 2012
Last Update Posted: February 13, 2014