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A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients

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: NCT01964547
Recruitment Status : Completed
First Posted : October 17, 2013
Results First Posted : May 2, 2014
Last Update Posted : May 2, 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: Treatment
Conditions Multiple Sclerosis
Spasticity
Interventions Drug: Sativex
Drug: Placebo
Enrollment 121
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sativex Placebo
Hide Arm/Group Description Each 100 μl actuation contains delta-9-tetrahydrocannabinol (THC) (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period. Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
Period Title: Overall Study
Started 62 59
Completed 50 48
Not Completed 12 11
Reason Not Completed
Adverse Event             8             2
Withdrawal by Subject             4             7
Lost to Follow-up             0             1
Withdrawal by Investigator             0             1
Arm/Group Title Sativex Placebo Total
Hide Arm/Group Description Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period. Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period. Total of all reporting groups
Overall Number of Baseline Participants 62 59 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 59 participants 121 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
61
  98.4%
58
  98.3%
119
  98.3%
>=65 years
1
   1.6%
1
   1.7%
2
   1.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 59 participants 121 participants
48.95  (8.954) 48.21  (10.381) 48.59  (9.642)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 59 participants 121 participants
Female
39
  62.9%
37
  62.7%
76
  62.8%
Male
23
  37.1%
22
  37.3%
45
  37.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Czech Republic Number Analyzed 62 participants 59 participants 121 participants
62 59 121
1.Primary Outcome
Title Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score.
Hide Description The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Stimulus presentation rates were adapted for use with multiple sclerosis patients. The PASAT is presented on audio compact disk to control the rate of stimulus presentation. Single digits are presented either every 3 seconds (PASAT 1) or every 2 seconds (PASAT 2), and the patient must add each new digit to the one immediately prior to it. The test score is the sum of the total number of correct sums given (out of 60 possible) in each trial. An increase in score indicates an improvement in condition.
Time Frame 0-48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
Overall Number of Participants Analyzed 55 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.8  (16.16) 6.8  (13.49)
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 group and center grouping as factors and the baseline score as covariate. The planned sample size was 120 participants(60 patients in the Sativex arm and 60 in the placebo arm).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The sample size is adequate to confirm the non-inferiority of Sativex with a clinical relevant reduction delta of 10%, assuming there is no difference between treatments in the actual change in cognition and also assuming a standard deviation for treatment difference of 10, using a one-tailed 2.5% significance level and power of 90%. Sativex is deemed to be non-inferior to placebo if the lower 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is greater than -10%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -1.47
Confidence Interval (1-Sided) 97.5%
-6.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.492
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to the End of Treatment in Beck Depression Inventory-II (BDI-II) Total Score.
Hide Description The BDI-II is a multiple choice self-reported inventory that is one of the most widely used instruments for measuring the severity of depression. There are 21 questions or items, each having four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. Items 1 to 13 assess symptoms that are psychological in nature, while items 14 to 21 assess symptoms that are more physical. The sum of all BDI-II item scores indicates the severity of depression. For patients eligible for this study, a score of 21 or over represents depression. The BDI-II can distinguish between different subtypes of depressive disorders, such as major depression and dysthymia. A reduction in score indicates an improvement in condition.
Time Frame 0-48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
Overall Number of Participants Analyzed 57 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.1  (7.76) -2.4  (6.38)
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 group and center grouping as factors and the baseline score as covariate.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sativex is deemed to be non-inferior to placebo if the upper 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is less than +5%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.29
Confidence Interval (1-Sided) 97.5%
2.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.323
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.
Hide Description

Patients were asked the following question, to be rated on a seven-point scale:

"Please assess the change in your spasticity since immediately before receiving the first dose of study treatment (Visit 1) using the scale below".

The markers were: 'Very much worse', 'Much worse', 'Minimally worse', 'No change', 'Minimally better', 'Much better' or 'Very much better'.

The number of patients for each of the markers is presented at the final study visit.

Time Frame 0-48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
Overall Number of Participants Analyzed 58 56
Measure Type: Number
Unit of Measure: participants
Very Much Better 2 0
Much Better 16 6
Minimally Better 24 15
No Change 13 27
Minimally Worse 1 7
Much Worse 2 1
Very Much Worse 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.02
Confidence Interval (2-Sided) 95%
1.96 to 8.22
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Hide Description

Caregivers were asked the following question to be rated on a seven-point scale:

"How has the subject's spasticity changed since Visit 1?" The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better.

The number of patients for each of the markers is presented at the final study visit.

Time Frame 0-48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
Overall Number of Participants Analyzed 41 40
Measure Type: Number
Unit of Measure: participants
Very Much Better 1 0
Much Better 12 6
Minimally Better 14 10
No Change 11 18
Minimally Worse 3 3
Much Worse 0 3
Very Much Worse 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0142
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.79
Confidence Interval (2-Sided) 95%
1.23 to 6.31
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.
Hide Description

Physicians were asked the following question to be rated on a seven-point scale:

"How has the subject's spasticity changed since Visit 1?" The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better.

The number of patients for each of the markers is presented at the final study visit.

Time Frame 0-48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
Overall Number of Participants Analyzed 58 56
Measure Type: Number
Unit of Measure: participants
Very Much Better 0 1
Much Better 15 6
Minimally Better 26 15
No Change 14 29
Minimally Worse 3 4
Much Worse 0 1
Very Much Worse 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.07
Confidence Interval (2-Sided) 95%
1.51 to 6.21
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to End of Treatment in Modified Ashworth Scale Total Score.
Hide Description All 20 muscle groups were assessed for spasticity (using a 0-5 scale): 0= 'no increase in muscle tone' to 5= 'affected part(s) rigid in flexion or extension'. The score for all 20 muscle groups were added to give a total score out of 100. A decrease in score indicates an improvement in condition.
Time Frame 0-48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
Overall Number of Participants Analyzed 58 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
-10.6  (11.26) -7.7  (10.70)
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 group and center grouping as factors and the baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.212
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -2.36
Confidence Interval (2-Sided) 95%
-6.09 to 1.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.880
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to End of Treatment in Number of Visits to a Healthcare Professional.
Hide Description At baseline, patients were asked how many times they had visited a healthcare professional in the previous 12 weeks. At subsequent visits, patients were asked how many times they had visited a healthcare professional since their last study visit. The change from baseline to the end of treatment is presented. A decrease in number indicates an improvement in condition.
Time Frame 0-48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
Overall Number of Participants Analyzed 58 56
Mean (Standard Deviation)
Unit of Measure: visits
-0.6  (0.99) -0.4  (1.30)
8.Secondary Outcome
Title The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study.
Hide Description Patients were scored at each clinic visit for the following outcomes using the C-SSRS: suicidal ideation, suicidal behaviour, suicidality (including complete suicidality). Possible flags were as follows: "Wish to be Dead", "Non-specific Active Suicidal Thoughts", "Active Suicidal Ideation Without Intent", "Active Suicidal Ideation With Intent, No Plan", "Active Suicidal Ideation With Intent and Plan". The number of patients with a treatment-emergent flag is presented.
Time Frame 0-48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
Overall Number of Participants Analyzed 62 59
Measure Type: Number
Unit of Measure: participants
Wish to be Dead 0 2
Non-specific Active Suicidal Thoughts 0 1
Active Suicidal Ideation Without Intent 0 1
Active Suicidal Ideation With Intent, No Plan 0 0
Active Suicidal Ideation With Intent and Plan 0 0
9.Secondary Outcome
Title Change From Baseline to End of Treatment in Timed 10-meter Walk Times.
Hide Description Only those patients for whom it was appropriate (i.e. ambulatory patients) were timed for how long it took to walk 10 metres. If a patient started the 10-meter walk but was unable to complete it, an estimated time for completion was calculated based on the available data. A negative difference from baseline indicates an improvement in condition.
Time Frame 0-48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: seconds
6.2  (55.34) 3.0  (24.68)
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 group and centre grouping as factors and baseline score as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.556
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 4.88
Confidence Interval (2-Sided) 95%
-11.51 to 21.27
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.250
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change at end of treatment was compared between treatment groups using non-parametric methods as the distribution of data was non-normal.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hodges-Lehmann median difference
Estimated Value -1
Confidence Interval (2-Sided) 95%
-3 to 0
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Incidence of Adverse Events as a Measure of Patient Safety.
Hide Description The number of subjects who experienced an adverse event during the course of the study is presented.
Time Frame 0-50 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
Overall Number of Participants Analyzed 62 59
Measure Type: Number
Unit of Measure: participants
39 19
Time Frame All adverse events occurring during the study (0-50 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 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period. Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 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   5/62 (8.06%)   0/59 (0.00%) 
Cardiac disorders     
Acute Myocardial Infarction  1 [1]  1/62 (1.61%)  0/59 (0.00%) 
Gastrointestinal disorders     
Inguinal Hernia  1  1/62 (1.61%)  0/59 (0.00%) 
General disorders     
Drug Withdrawal Syndrome  1  1/62 (1.61%)  0/59 (0.00%) 
Infections and infestations     
Bronchitis  1  1/62 (1.61%)  0/59 (0.00%) 
Pneumonia  1  1/62 (1.61%)  0/59 (0.00%) 
Injury, poisoning and procedural complications     
Overdose  1  1/62 (1.61%)  0/59 (0.00%) 
Metabolism and nutrition disorders     
Tetany  1  1/62 (1.61%)  0/59 (0.00%) 
Nervous system disorders     
Dysarthria  1  1/62 (1.61%)  0/59 (0.00%) 
Psychiatric disorders     
Disorientation  1  1/62 (1.61%)  0/59 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
[1]
The acute myocardial infarction resulted in the affected participant's death; this was not considered to be treatment-related.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   34/62 (54.84%)   19/59 (32.20%) 
Ear and labyrinth disorders     
Vertigo  1  6/62 (9.68%)  0/59 (0.00%) 
Eye disorders     
Visual Impairment  1  0/62 (0.00%)  1/59 (1.69%) 
Gastrointestinal disorders     
Diarrhoea  1  1/62 (1.61%)  0/59 (0.00%) 
Dry Mouth  1  2/62 (3.23%)  0/59 (0.00%) 
Gingivitis  1  0/62 (0.00%)  2/59 (3.39%) 
Nausea  1  1/62 (1.61%)  1/59 (1.69%) 
Oral Mucosal Erythema  1  0/62 (0.00%)  1/59 (1.69%) 
Vomiting  1  1/62 (1.61%)  0/59 (0.00%) 
General disorders     
Asthenia  1  2/62 (3.23%)  0/59 (0.00%) 
Fatigue  1  5/62 (8.06%)  1/59 (1.69%) 
Pyrexia  1  0/62 (0.00%)  1/59 (1.69%) 
Application Site Discomfort  1  1/62 (1.61%)  0/59 (0.00%) 
Immune system disorders     
Drug Hypersensitivity  1  0/62 (0.00%)  1/59 (1.69%) 
Infections and infestations     
Bacterial Infection  1  1/62 (1.61%)  0/59 (0.00%) 
Herpes Zoster  1  1/62 (1.61%)  0/59 (0.00%) 
Subcutaneous Abscess  1  0/62 (0.00%)  1/59 (1.69%) 
Tonsillitis  1  2/62 (3.23%)  0/59 (0.00%) 
Upper Respiratory Tract Infection  1  0/62 (0.00%)  3/59 (5.08%) 
Upper Respiratory Tract Infection Bacterial  1  0/62 (0.00%)  1/59 (1.69%) 
Urinary Tract Infection  1  5/62 (8.06%)  1/59 (1.69%) 
Viral Infection  1  0/62 (0.00%)  2/59 (3.39%) 
Injury, poisoning and procedural complications     
Contusion  1  1/62 (1.61%)  1/59 (1.69%) 
Face Injury  1  1/62 (1.61%)  0/59 (0.00%) 
Foot Fracture  1  0/62 (0.00%)  1/59 (1.69%) 
Forearm Fracture  1  0/62 (0.00%)  1/59 (1.69%) 
Joint Dislocation  1  1/62 (1.61%)  1/59 (1.69%) 
Ligament Sprain  1  0/62 (0.00%)  1/59 (1.69%) 
Lower Limb Fracture  1  1/62 (1.61%)  0/59 (0.00%) 
Procedural Vomiting  1  1/62 (1.61%)  0/59 (0.00%) 
Thermal Burn  1  1/62 (1.61%)  0/59 (0.00%) 
Upper Limb Fracture  1  1/62 (1.61%)  0/59 (0.00%) 
Investigations     
Blood Alkaline Phosphatase Increased  1  0/62 (0.00%)  1/59 (1.69%) 
Vitamin D Decreased  1  0/62 (0.00%)  1/59 (1.69%) 
Weight Decreased  1  3/62 (4.84%)  0/59 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite  1  1/62 (1.61%)  0/59 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  1/62 (1.61%)  0/59 (0.00%) 
Muscle Spasms  1  1/62 (1.61%)  0/59 (0.00%) 
Pain In Extremity  1  1/62 (1.61%)  0/59 (0.00%) 
Nervous system disorders     
Cerebellar Ataxia  1  2/62 (3.23%)  0/59 (0.00%) 
Cognitive Disorder  1  0/62 (0.00%)  1/59 (1.69%) 
Dizziness  1  5/62 (8.06%)  0/59 (0.00%) 
Headache  1  1/62 (1.61%)  2/59 (3.39%) 
Memory Impairment  1  1/62 (1.61%)  0/59 (0.00%) 
Multiple Sclerosis  1  1/62 (1.61%)  0/59 (0.00%) 
Multiple Sclerosis Relapse  1  3/62 (4.84%)  4/59 (6.78%) 
Muscle Spasticity  1  5/62 (8.06%)  2/59 (3.39%) 
Neuralgia  1  2/62 (3.23%)  0/59 (0.00%) 
Paraesthesia  1  1/62 (1.61%)  1/59 (1.69%) 
Paraparesis  1  0/62 (0.00%)  1/59 (1.69%) 
Radiculopathy  1  1/62 (1.61%)  0/59 (0.00%) 
Somnolence  1  1/62 (1.61%)  1/59 (1.69%) 
Stupor  1  1/62 (1.61%)  0/59 (0.00%) 
Tremor  1  1/62 (1.61%)  0/59 (0.00%) 
Trigeminal Neuralgia  1  1/62 (1.61%)  0/59 (0.00%) 
Psychiatric disorders     
Anxiety Disorder Due To A General Medical Condition  1  2/62 (3.23%)  0/59 (0.00%) 
Euphoric Mood  1  2/62 (3.23%)  0/59 (0.00%) 
Suicidal Ideation  1  0/62 (0.00%)  1/59 (1.69%) 
Reproductive system and breast disorders     
Erectile Dysfunction  1  0/62 (0.00%)  1/59 (1.69%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal Blistering  1  0/62 (0.00%)  1/59 (1.69%) 
Skin and subcutaneous tissue disorders     
Dermatitis Allergic  1  1/62 (1.61%)  0/59 (0.00%) 
Surgical and medical procedures     
Lipoma Excision  1  0/62 (0.00%)  1/59 (1.69%) 
Tooth Extraction  1  1/62 (1.61%)  0/59 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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 Pharma Ltd (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: NCT01964547    
Other Study ID Numbers: GWMS1137
First Submitted: October 15, 2013
First Posted: October 17, 2013
Results First Submitted: October 29, 2013
Results First Posted: May 2, 2014
Last Update Posted: May 2, 2014