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GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

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ClinicalTrials.gov Identifier: NCT02224703
Recruitment Status : Completed
First Posted : August 25, 2014
Results First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Epilepsy
Dravet Syndrome
Interventions Drug: GWP42003-P
Drug: Placebo Control
Enrollment 199
Recruitment Details A total of 43 sites screened participants and 38 sites (23 in the United States, 7 in Spain, 3 in Poland, 2 in Australia, 1 in Israel, and 2 in the Netherlands) randomized participants into the trial. Two sites selected (1 in Israel and 1 in the United States) did not screen any participants.
Pre-assignment Details To assess eligibility, participants, 2–18 years of age with Dravet syndrome had to be taking 1 or more antiepileptic drugs at a dose which had been stable; and medicated for epilepsy for at least 4 weeks were screened. A total of 285 participants were screened, of which 199 were randomized.
Arm/Group Title 10 mg/kg/Day GWP42003-P 20 mg/kg/Day GWP42003-P Placebo Control
Hide Arm/Group Description GWP42003-P oral solution (100 milligrams/milliliter [mg/mL] cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 10 mg/kilogram (kg)/day dose was defined as 50% of the 20 mg/kg/day dose. GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring).The 20 mg/kg/day dose was recommended by the Data Safety Monitoring Committee (DSMC) after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206). Excipients only. Participants were pooled from 2 placebo cohorts, half receiving 10 mg/kg/day dose-volume equivalent and half receiving 20 mg/kg/day dose-volume equivalent.
Period Title: Overall Study
Started 67 67 65
Received at Least 1 Dose of Study Drug 66 67 65
Safety Analysis Set [1] 64 [2] 69 [2] 65
Intent to Treat (ITT) Analysis Set [3] 66 67 65
Completed 64 61 65
Not Completed 3 6 0
Reason Not Completed
Adverse Event             0             5             0
Withdrawn by investigator             1             0             0
Advised by medical monitor             1             0             0
Withdrawn by parent/guardian             0             1             0
Lack of Efficacy             1             0             0
[1]
Received at least 1 dose of study drug and analyzed as per actual treatment received
[2]
Two participants assigned to the 10 mg/kg/day dose were included in the 20 mg/kg/day group
[3]
Randomized, received study drug, and had post-baseline efficacy data
Arm/Group Title 10 mg/kg/Day GWP42003-P 20 mg/kg/Day GWP42003-P Placebo Control Total
Hide Arm/Group Description GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 10 mg/kg/day dose was defined as 50% of the 10 mg/kg/day dose. GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 20 mg/kg/day dose was recommended by the DSMC after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206). Excipients only. Participants were pooled from 2 placebo cohorts, half receiving 10 mg/kg/day dose-volume equivalent and half receiving 20 mg/kg/day dose-volume equivalent. Total of all reporting groups
Overall Number of Baseline Participants 64 69 65 198
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 69 participants 65 participants 198 participants
9.169  (4.1744) 9.245  (4.3792) 9.617  (4.5757) 9.343  (4.3626)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 69 participants 65 participants 198 participants
Female
38
  59.4%
32
  46.4%
34
  52.3%
104
  52.5%
Male
26
  40.6%
37
  53.6%
31
  47.7%
94
  47.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 69 participants 65 participants 198 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   1.5%
1
   0.5%
Asian
0
   0.0%
1
   1.4%
4
   6.2%
5
   2.5%
Black or African American
1
   1.6%
0
   0.0%
4
   6.2%
5
   2.5%
White
55
  85.9%
66
  95.7%
55
  84.6%
176
  88.9%
Other
8
  12.5%
2
   2.9%
1
   1.5%
11
   5.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants 69 participants 65 participants 198 participants
Australia 6 4 3 13
Israel 0 1 2 3
Netherlands 9 7 9 25
Poland 8 11 6 25
Spain 12 14 13 39
United States 29 32 32 93
1.Primary Outcome
Title Change In Convulsive Seizures During The Treatment Period Compared To Baseline
Hide Description Convulsive seizures were defined as tonic–clonic, tonic, clonic, or atonic. Participants or their caregivers recorded the number and type of convulsive seizures each day from screening until completion of dosing using an interactive voice response system (IVRS) diary. The primary endpoint was analyzed using negative binomial regression on the sum of the convulsive seizure counts during the treatment period, based on the ITT analysis set. Baseline included all available data prior to Day 1. Data reported as the ratio of geometric least squares mean in convulsive seizures and expressed as a percentage reduction.
Time Frame Baseline to Day 99 or Early Termination (ET)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set: All participants who were randomized and dosed in the trial and had post-baseline efficacy data.
Arm/Group Title 10 mg/kg/Day GWP42003-P 20 mg/kg/Day GWP42003-P Placebo Control
Hide Arm/Group Description:
GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 10 mg/kg/day dose was defined as 50% of the 20 mg/kg/day dose.
GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 20 mg/kg/day dose was recommended by the DSMC after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206).
Excipients only. Participants were pooled from 2 placebo cohorts, half receiving 10 mg/kg/day dose-volume equivalent and half receiving 20 mg/kg/day dose-volume equivalent.
Overall Number of Participants Analyzed 66 67 65
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage reduction
48.7
(37.9 to 57.6)
45.7
(34.2 to 55.2)
26.9
(11.9 to 39.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg/kg/Day GWP42003-P, Placebo Control
Comments Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0299
Comments [Not Specified]
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Ratio
Estimated Value 0.743
Confidence Interval (2-Sided) 95%
0.568 to 0.971
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 10 mg/kg/Day GWP42003-P, Placebo Control
Comments Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0095
Comments [Not Specified]
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Ratio
Estimated Value 0.702
Confidence Interval (2-Sided) 95%
0.538 to 0.916
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change In Total Seizures During The Treatment Period Compared To Baseline
Hide Description Total seizures were defined as the combination of convulsive and non-convulsive seizures. Convulsive seizures were defined as tonic–clonic, tonic, clonic, or atonic seizures. Non-convulsive seizures were defined as myoclonic, countable partial, other partial, or absence seizures. Participants or their caregivers recorded the number and type of convulsive seizures and non-convulsive seizures each day from screening until completion of dosing using an IVRS diary. Change compared to baseline was calculated as per the primary outcome measure. Data reported as the ratio of geometric least squares mean in total seizures and expressed as a percentage reduction.
Time Frame Baseline to Day 99 or ET
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set: All participants who were randomized and dosed in the trial and had post-baseline efficacy data.
Arm/Group Title 10 mg/kg/Day GWP42003-P 20 mg/kg/Day GWP42003-P Placebo Control
Hide Arm/Group Description:
GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 10 mg/kg/day dose was defined as 50% of the 10 mg/kg/day dose.
GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 20 mg/kg/day dose was recommended by the DSMC after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206).
Excipients only. Participants were pooled from 2 placebo cohorts, half receiving 10 mg/kg/day dose-volume equivalent and half receiving 20 mg/kg/day dose-volume equivalent.
Overall Number of Participants Analyzed 66 67 65
Geometric Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage reduction
56.4
(47.8 to 63.6)
47.3
(36.9 to 56.0)
29.7
(16.0 to 41.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg/kg/Day GWP42003-P, Placebo Control
Comments Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0255
Comments [Not Specified]
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Ratio
Estimated Value 0.749
Confidence Interval (2-Sided) 95%
0.581 to 0.965
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 10 mg/kg/Day GWP42003-P, Placebo Control
Comments Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Ratio
Estimated Value 0.620
Confidence Interval (2-Sided) 95%
0.481 to 0.799
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period
Hide Description Convulsive seizures were defined as tonic–clonic, tonic, clonic, or atonic. Participants or their caregivers recorded the number and type of convulsive seizures each day from screening until completion of dosing using an IVRS diary. Baseline included all available data prior to Day 1 (28-day average). Percentage change from baseline was calculated as: ([frequency during the treatment period - frequency during baseline]/frequency during baseline) x 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) x 28. Baseline included all available data prior to Day 1 (28-day average).
Time Frame Baseline to Day 99 or ET
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set: All participants who were randomized and dosed in the trial and had post-baseline efficacy data.
Arm/Group Title 10 mg/kg/Day GWP42003-P 20 mg/kg/Day GWP42003-P Placebo Control
Hide Arm/Group Description:
GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 10 mg/kg/day dose was defined as 50% of the 10 mg/kg/day dose.
GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 20 mg/kg/day dose was recommended by the DSMC after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206).
Excipients only. Participants were pooled from 2 placebo cohorts, half receiving 10 mg/kg/day dose-volume equivalent and half receiving 20 mg/kg/day dose-volume equivalent.
Overall Number of Participants Analyzed 66 67 65
Measure Type: Count of Participants
Unit of Measure: Participants
29
  43.9%
33
  49.3%
17
  26.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg/kg/Day GWP42003-P, Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0069
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value calculated from a Cochran–Mantel–Haenszel test stratified by age group (2–5, 6–12, and 13–18 years).
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.74
Confidence Interval (2-Sided) 95%
1.32 to 5.70
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 10 mg/kg/Day GWP42003-P, Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0332
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value calculated from a Cochran–Mantel–Haenszel test stratified by age group (2–5, 6–12, and 13–18 years).
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.21
Confidence Interval (2-Sided) 95%
1.06 to 4.62
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Caregiver Global Impression Of Change (CGIC) At The Last Visit
Hide Description On Day 1 (prior to receiving study drug), the caregiver was asked to write a brief description of the participant’s overall condition as a memory aid for the CGIC questionnaire at subsequent visits. The CGIC questionnaire comprised the following question, to be rated on a 7-point scale: Since your child started treatment, please assess the status of your child’s overall condition (comparing their condition now to their condition before treatment) using the scale below. The markers were: “Very Much Improved”; “Much Improved”; “Slightly Improved”; “No Change”; “Slightly Worse”; “Much Worse”; “Very Much Worse”. The CGIC response/score, recorded at each visit, was summarized, on both a categorical and continuous scale, by treatment group. The scores at the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant’s last evaluation was performed were analyzed using ordinal logistic regression.
Time Frame Baseline to Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set: All participants who were randomized and dosed in the trial and had post-baseline efficacy data.
Arm/Group Title 10 mg/kg/Day GWP42003-P 20 mg/kg/Day GWP42003-P Placebo Control
Hide Arm/Group Description:
GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 10 mg/kg/day dose was defined as 50% of the 10 mg/kg/day dose.
GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 20 mg/kg/day dose was recommended by the DSMC after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206).
Excipients only. Participants were pooled from 2 placebo cohorts, half receiving 10 mg/kg/day dose-volume equivalent and half receiving 20 mg/kg/day dose-volume equivalent.
Overall Number of Participants Analyzed 66 66 65
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Improved
13
  19.7%
11
  16.7%
1
   1.5%
Much Improved
11
  16.7%
10
  15.2%
8
  12.3%
Slightly Improved
21
  31.8%
19
  28.8%
18
  27.7%
No Change
18
  27.3%
17
  25.8%
32
  49.2%
Slightly Worse
2
   3.0%
5
   7.6%
4
   6.2%
Much Worse
1
   1.5%
3
   4.5%
2
   3.1%
Very Much Worse
0
   0.0%
1
   1.5%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 20 mg/kg/Day GWP42003-P, Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0279
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.02
Confidence Interval (2-Sided) 95%
1.08 to 3.78
Estimation Comments Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 10 mg/kg/Day GWP42003-P, Placebo Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.93
Confidence Interval (2-Sided) 95%
1.56 to 5.53
Estimation Comments Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.
Time Frame From Day 1 to Day 137.
Adverse Event Reporting Description Safety Analysis Set: Received at least 1 dose of study drug and were analyzed per treatment received. Two participants randomized to receive GWP42003-P 10 mg/kg/day titrated above the target dose and were therefore assigned to the GWP42003-P 20 mg/kg/day group for all safety analyses.
 
Arm/Group Title 10 mg/kg/Day GWP42003-P 20 mg/kg/Day GWP42003-P Placebo Control
Hide Arm/Group Description GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 10 mg/kg/day dose was defined as 50% of the 10 mg/kg/day dose. GWP42003-P oral solution (100 mg/mL cannabidiol in sesame oil with anhydrous ethanol with added sweetener [sucralose] and strawberry flavoring). The 20 mg/kg/day dose was recommended by the DSMC after assessment of safety and pharmacokinetic data from Part A of study GWEP1332 (NCT02091206). Excipients only. Participants were pooled from 2 placebo cohorts, half receiving 10 mg/kg/day dose-volume equivalent and half receiving 20 mg/kg/day dose-volume equivalent.
All-Cause Mortality
10 mg/kg/Day GWP42003-P 20 mg/kg/Day GWP42003-P Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)   0/69 (0.00%)   0/65 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
10 mg/kg/Day GWP42003-P 20 mg/kg/Day GWP42003-P Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/64 (20.31%)   17/69 (24.64%)   10/65 (15.38%) 
Gastrointestinal disorders       
Constipation  1  0/64 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
General disorders       
Pyrexia  1  1/64 (1.56%)  1/69 (1.45%)  0/65 (0.00%) 
Drug interaction  1  0/64 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
Fatigue  1  0/64 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
Infections and infestations       
Pneumonia  1  3/64 (4.69%)  2/69 (2.90%)  0/65 (0.00%) 
Viral infection  1  1/64 (1.56%)  1/69 (1.45%)  0/65 (0.00%) 
Coxsackie viral infection  1  0/64 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
Gastroenteritis  1  0/64 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
Sepsis  1  0/64 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
Adenovirus infection  1  1/64 (1.56%)  0/69 (0.00%)  0/65 (0.00%) 
Laryngitis  1  1/64 (1.56%)  0/69 (0.00%)  0/65 (0.00%) 
Respiratory tract infection  1  1/64 (1.56%)  0/69 (0.00%)  0/65 (0.00%) 
Viral upper respiratory tract infection  1  0/64 (0.00%)  0/69 (0.00%)  1/65 (1.54%) 
Injury, poisoning and procedural complications       
Toxicity to various agents  1  1/64 (1.56%)  1/69 (1.45%)  0/65 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  0/64 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
Aspartate aminotransferase increased  1  0/64 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
Liver function test abnormal  1  0/64 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  1/64 (1.56%)  1/69 (1.45%)  0/65 (0.00%) 
Nervous system disorders       
Status epilepticus  1  5/64 (7.81%)  7/69 (10.14%)  8/65 (12.31%) 
Generalised tonic-clonic seizure  1  0/64 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
Convulsion  1  3/64 (4.69%)  0/69 (0.00%)  1/65 (1.54%) 
Somnolence  1  2/64 (3.13%)  0/69 (0.00%)  0/65 (0.00%) 
Seizure cluster  1  1/64 (1.56%)  0/69 (0.00%)  2/65 (3.08%) 
Unresponsive to stimuli  1  1/64 (1.56%)  0/69 (0.00%)  0/65 (0.00%) 
Psychiatric disorders       
Psychogenic seizure  1  1/64 (1.56%)  0/69 (0.00%)  0/65 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory depression  1  0/64 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
Respiratory distress  1  0/64 (0.00%)  0/69 (0.00%)  1/65 (1.54%) 
Pneumonia aspiration  1  1/64 (1.56%)  2/69 (2.90%)  0/65 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash  1  0/64 (0.00%)  1/69 (1.45%)  0/65 (0.00%) 
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
10 mg/kg/Day GWP42003-P 20 mg/kg/Day GWP42003-P Placebo Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   56/64 (87.50%)   60/69 (86.96%)   58/65 (89.23%) 
Gastrointestinal disorders       
Diarrhoea  1  11/64 (17.19%)  18/69 (26.09%)  8/65 (12.31%) 
Vomiting  1  4/64 (6.25%)  11/69 (15.94%)  4/65 (6.15%) 
General disorders       
Pyrexia  1  15/64 (23.44%)  14/69 (20.29%)  11/65 (16.92%) 
Fatigue  1  5/64 (7.81%)  14/69 (20.29%)  7/65 (10.77%) 
Infections and infestations       
Nasopharyngitis  1  4/64 (6.25%)  8/69 (11.59%)  5/65 (7.69%) 
Upper respiratory tract infection  1  3/64 (4.69%)  4/69 (5.80%)  3/65 (4.62%) 
Urinary tract infection  1  0/64 (0.00%)  4/69 (5.80%)  1/65 (1.54%) 
Injury, poisoning and procedural complications       
Toxicity to various agents  1  1/64 (1.56%)  4/69 (5.80%)  0/65 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  3/64 (4.69%)  8/69 (11.59%)  0/65 (0.00%) 
Aspartate aminotransferase increased  1  3/64 (4.69%)  8/69 (11.59%)  0/65 (0.00%) 
Gamma-glutamyltransferase increased  1  4/64 (6.25%)  4/69 (5.80%)  3/65 (4.62%) 
Metabolism and nutrition disorders       
Decreased appetite  1  10/64 (15.63%)  19/69 (27.54%)  11/65 (16.92%) 
Nervous system disorders       
Somnolence  1  14/64 (21.88%)  16/69 (23.19%)  9/65 (13.85%) 
Convulsion  1  3/64 (4.69%)  4/69 (5.80%)  4/65 (6.15%) 
Tremor  1  0/64 (0.00%)  4/69 (5.80%)  0/65 (0.00%) 
Psychiatric disorders       
Aggression  1  1/64 (1.56%)  6/69 (8.70%)  2/65 (3.08%) 
Irritability  1  3/64 (4.69%)  5/69 (7.25%)  2/65 (3.08%) 
Abnormal behaviour  1  0/64 (0.00%)  4/69 (5.80%)  0/65 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Nasal congestion  1  0/64 (0.00%)  1/69 (1.45%)  4/65 (6.15%) 
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Enquiries
Organization: GW Research Ltd
Phone: +44 01223 238170; +18778862810
EMail: medinfo@gwpharm.com; medinfo@greenwichbiosciences.com
Layout table for additonal information
Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT02224703     History of Changes
Other Study ID Numbers: GWEP1424
2014-002939-34 ( EudraCT Number )
First Submitted: August 21, 2014
First Posted: August 25, 2014
Results First Submitted: July 11, 2019
Results First Posted: August 1, 2019
Last Update Posted: August 1, 2019