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A Study to Evaluate the Efficacy of Sativex in Relieving Symptoms of Spasticity Due to Multiple Sclerosis

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: NCT01599234
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : August 16, 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: Treatment
Condition Multiple Sclerosis
Interventions Drug: Sativex
Drug: Placebo
Enrollment 337
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 delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours. Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Period Title: Overall Study
Started 167 170
Completed 150 155
Not Completed 17 15
Reason Not Completed
Adverse Event             9             5
Withdrawal by Subject             2             1
Lost to Follow-up             1             2
Lack of Efficacy             2             4
Unable to operate spray             1             0
Sponsor request as creatinine levels <50             0             1
Death             1             0
Patient would not stop driving             1             0
Contra-indication discovered             0             1
Pregnancy             0             1
Arm/Group Title Sativex Placebo Total
Hide Arm/Group Description Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours. Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours. Total of all reporting groups
Overall Number of Baseline Participants 167 170 337
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 170 participants 337 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
162
  97.0%
168
  98.8%
330
  97.9%
>=65 years
5
   3.0%
2
   1.2%
7
   2.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 167 participants 170 participants 337 participants
48.0  (10.06) 47.1  (9.15) 47.5  (9.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 170 participants 337 participants
Female
106
  63.5%
101
  59.4%
207
  61.4%
Male
61
  36.5%
69
  40.6%
130
  38.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 167 participants 170 participants 337 participants
United Kingdom 65 63 128
Czech Republic 102 107 209
1.Primary Outcome
Title Change From Baseline in Mean Spasticity 0-10 Numerical Rating Scale (NRS) Score During the Last 14 Day of Treatment (End of Treatment)
Hide Description The average spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked "on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours" where 0 = no spasticity and 10 = worst possible spasticity. A negative value indicates an improvement in pain score from baseline.
Time Frame 0-15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation 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 delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 166 169
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.22  (1.76) -0.91  (1.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The initial model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline as a covariate and treatment group, centre group, ambulatory status at baseline and previous use of cannabis as main effects. Interactions between the main effects were investigated, and if they had little influence then they were dropped from the model. These tests were performed at the 10% significance level as a possible indicator of an interactive effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.220
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.23
Confidence Interval 95%
-0.59 to 0.14
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Subjects With a 30% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline
Hide Description The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 30% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked "on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours" where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 30% level is presented.
Time Frame 0-15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation 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 delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 166 169
Measure Type: Number
Unit of Measure: participants
51 42
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.231
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.341
Confidence Interval (2-Sided) 95%
0.830 to 2.167
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Mean Modified Ashworth Scale Score at the End of Treatment
Hide Description All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.
Time Frame Day 0 (Randomisation) and Day 99 (End of Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation 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 delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 156 160
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.3  (9.25) -2.8  (7.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.857
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.16
Confidence Interval (2-Sided) 95%
-1.94 to 1.61
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Mean Sleep Quality 0-10 NRS During the Last 14 Days of Treatment (End of Treatment)
Hide Description The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked "on a scale of '0 to 10', please indicate how your spasticity 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 0-15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation 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 delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 124 139
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.7  (2.85) -0.6  (2.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.734
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.55 to 0.40
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Incidence of Adverse Events as a Measure of Subject Safety
Hide Description The number of subjects who experienced and adverse event during the course of the study is presented
Time Frame 0-15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis, as were a further two subjects who were excluded from the full analysis set (used for the efficacy analysis) as a result of no on-treatment efficacy data
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 167 170
Measure Type: Number
Unit of Measure: participants
156 132
6.Secondary Outcome
Title Change From Baseline in Mean Timed 10 Metre Walk Time at the End of Treatment
Hide Description Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk. A negative difference from baseline indicates an improvement walk time.
Time Frame Day 0 (Randomisation) and Day 99 (End of Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation 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 delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 115 120
Mean (Standard Deviation)
Unit of Measure: time (seconds)
-2.1  (17.37) 9.3  (63.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.624
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-2.0 to 1.0
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Carer Global Impression of Change at the End of Treatment
Hide Description The carer of the subject gave their opinion of any noticeable change in the subject's overall functional ability at the end of the study. A 7-point Likert-type scale was used, with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". The number of carers who reported an improvement at the end of treatment is presented.
Time Frame Day 99 (end of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis, as were a further two subjects who were excluded from the full analysis set as a result of no on-treatment efficacy data
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 167 170
Measure Type: Number
Unit of Measure: participants
72 56
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The two treatment groups were to be compared using ordinal logistic regression and the proportional odds model. The model was to incorporate ambulatory status at baseline and centre group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.270
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.248
Confidence Interval (2-Sided) 95%
0.842 to 1.849
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Mean Total Barthel Activities of Daily Living Index Score at the End of Treatment
Hide Description The Barthel Index consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The person receives a score based on whether they have received help while doing the task. The scores for each of the items are summed to create a total score of 100. An increase in score indicates an improvement.
Time Frame Day 0 (Randomisation) and Day 99 (End of Treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation 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 delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 162 165
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.1  (10.26) 0.5  (8.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.867
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-1.95 to 1.64
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Subjects With a 50% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline
Hide Description The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 50% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked "on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours" where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 50% level is presented.
Time Frame 0 - 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation 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 delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 166 169
Measure Type: Number
Unit of Measure: participants
21 18
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.569
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.215
Confidence Interval (2-Sided) 95%
0.622 to 2.373
Estimation Comments [Not Specified]
Time Frame All adverse events occurring from the time of consent to post study follow up were collected (Days 0 - 134). 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 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 delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours. Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
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   15/167 (8.98%)   7/170 (4.12%) 
General disorders     
Irritability  1 [1]  1/167 (0.60%)  0/170 (0.00%) 
Asthenia  1  1/167 (0.60%)  0/170 (0.00%) 
Infections and infestations     
Urinary Tract Infection  1  3/167 (1.80%)  2/170 (1.18%) 
Orchitis  1  1/167 (0.60%)  0/170 (0.00%) 
Erysipelas  1  0/167 (0.00%)  2/170 (1.18%) 
Sepsis  1  0/167 (0.00%)  2/170 (1.18%) 
Injury, poisoning and procedural complications     
Burns third degree  1  1/167 (0.60%)  0/170 (0.00%) 
Fall  1  1/167 (0.60%)  0/170 (0.00%) 
Foot Fracture  1  1/167 (0.60%)  0/170 (0.00%) 
Road Traffic Accident  1  0/167 (0.00%)  1/170 (0.59%) 
Metabolism and nutrition disorders     
Dehydration  1  1/167 (0.60%)  0/170 (0.00%) 
Tetany  1  0/167 (0.00%)  1/170 (0.59%) 
Musculoskeletal and connective tissue disorders     
Muscle Spasms  1  1/167 (0.60%)  0/170 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon Cancer  1  1/167 (0.60%)  0/170 (0.00%) 
Metastases to Liver  1  1/167 (0.60%)  0/170 (0.00%) 
Oesophageal Adenocarcinoma Metastatic  1  1/167 (0.60%)  0/170 (0.00%) 
Nervous system disorders     
Multiple Sclerosis Relapse  1  2/167 (1.20%)  1/170 (0.59%) 
Epilepsy  1  1/167 (0.60%)  0/170 (0.00%) 
Muscle Spasticity  1  1/167 (0.60%)  0/170 (0.00%) 
Somnolence  1  1/167 (0.60%)  0/170 (0.00%) 
Psychiatric disorders     
Aggression  1  1/167 (0.60%)  0/170 (0.00%) 
Agitation  1  1/167 (0.60%)  0/170 (0.00%) 
Confusional State  1  1/167 (0.60%)  0/170 (0.00%) 
Depression  1  1/167 (0.60%)  0/170 (0.00%) 
Drug Dependence  1  1/167 (0.60%)  0/170 (0.00%) 
Insomnia  1  1/167 (0.60%)  0/170 (0.00%) 
Paranoia  1  1/167 (0.60%)  0/170 (0.00%) 
Suicidal Ideation  1  1/167 (0.60%)  0/170 (0.00%) 
Delusions  1  1/167 (0.60%)  0/170 (0.00%) 
Depression Worsened  1  1/167 (0.60%)  0/170 (0.00%) 
Renal and urinary disorders     
Urinary Retention  1  1/167 (0.60%)  1/170 (0.59%) 
Respiratory, thoracic and mediastinal disorders     
Haemoptysis  1  1/167 (0.60%)  0/170 (0.00%) 
Skin and subcutaneous tissue disorders     
Decubitus Ulcer  1  1/167 (0.60%)  0/170 (0.00%) 
Vascular disorders     
Peripheral Ischaemia  1  1/167 (0.60%)  0/170 (0.00%) 
Phlebothrombosis  1  0/167 (0.00%)  1/170 (0.59%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
[1]
Irritability may have been misclassified to the General Disorders and Administration Site Conditions SOC from the Psychiatric Disorders SOC.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   156/167 (93.41%)   132/170 (77.65%) 
Ear and labyrinth disorders     
Vertigo  1  19/167 (11.38%)  7/170 (4.12%) 
Gastrointestinal disorders     
Nausea  1  53/167 (31.74%)  17/170 (10.00%) 
Dry Mouth  1  24/167 (14.37%)  7/170 (4.12%) 
Diarrhoea  1  15/167 (8.98%)  10/170 (5.88%) 
Vomiting  1  9/167 (5.39%)  0/170 (0.00%) 
Dyspepsia  1  7/167 (4.19%)  0/170 (0.00%) 
Constipation  1  7/167 (4.19%)  0/170 (0.00%) 
General disorders     
Fatigue  1  42/167 (25.15%)  32/170 (18.82%) 
Asthenia  1  26/167 (15.57%)  11/170 (6.47%) 
Feeling Abnormal  1  6/167 (3.59%)  1/170 (0.59%) 
Malaise  1  6/167 (3.59%)  1/170 (0.59%) 
Infections and infestations     
Urinary Tract Infection Not Otherwise Specified  1  19/167 (11.38%)  21/170 (12.35%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  7/167 (4.19%)  1/170 (0.59%) 
Muscle Spasms  1  7/167 (4.19%)  5/170 (2.94%) 
Nervous system disorders     
Dizziness  1  53/167 (31.74%)  17/170 (10.00%) 
Somnolence  1  24/167 (14.37%)  7/170 (4.12%) 
Muscle Spasticity  1  17/167 (10.18%)  13/170 (7.65%) 
Headache  1  15/167 (8.98%)  10/170 (5.88%) 
Dysgeusia  1  9/167 (5.39%)  0/170 (0.00%) 
Disturbance in Attention  1  7/167 (4.19%)  0/170 (0.00%) 
Dysarthria  1  7/167 (4.19%)  0/170 (0.00%) 
Multiple Sclerosis Relapse  1  5/167 (2.99%)  5/170 (2.94%) 
Psychiatric disorders     
Insomnia  1  4/167 (2.40%)  5/170 (2.94%) 
Anxiety  1  1/167 (0.60%)  5/170 (2.94%) 
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
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Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01599234    
Other Study ID Numbers: GWCL0403
First Submitted: May 10, 2012
First Posted: May 15, 2012
Results First Submitted: July 11, 2012
Results First Posted: August 16, 2012
Last Update Posted: June 24, 2013