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Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults (GWPCARE3)

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: NCT02224560
Recruitment Status : Completed
First Posted : August 25, 2014
Results First Posted : July 27, 2018
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Epilepsy
Lennox Gastaut Syndrome
Interventions Drug: GWP42003-P
Drug: Placebo control
Enrollment 225
Recruitment Details  
Pre-assignment Details The dose levels of 10 and 20 milligram (mg) per kilogram (kg) per day (mg/kg/day) were recommended by the Data Safety Monitoring Committee (DSMC) of study GWEP1332 Part A (NCT02091206) after assessment of safety and pharmacokinetic data. Participants of GWEP1414 were not enrolled until the DSMC had reviewed the safety data of GWEP1332 Part A.
Arm/Group Title GWP42003-P 20 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose Placebo
Hide Arm/Group Description Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the open-label extension (OLE) study, the maintenance period was followed by a 10-day taper (10% per day) period. Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period. Participants received placebo (0 mg/milliliter [mL] cannabidiol [CBD]), volume matched to 1 of the 2 dose levels (10 or 20 mg/kg/day), administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 7 to 11 days according to the matched investigational medicinal product (IMP) group (7 or 11 days for the 10 or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day of the matched dose) period.
Period Title: Overall Study
Started 76 73 76
Safety Analysis Set [1] 82 [2] 67 [2] 76
Intent to Treat (ITT) Analysis Set [3] 76 73 76
Completed 67 71 74
Not Completed 9 2 2
Reason Not Completed
Protocol Deviation             1             0             0
Withdrawal by Subject             2             0             1
Met Withdrawal Criteria             1             0             0
Adverse Event             4             1             1
Withdrawn by Investigator             1             1             0
[1]
Received at least 1 dose of IMP; analyzed as per actual treatment received.
[2]
Six participants assigned to the 10 mg/kg/day dose were included in the 20 mg/kg/day group.
[3]
Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement.
Arm/Group Title GWP42003-P 20 mg/kg/Day Dose-ITT Analysis Set GWP42003-P 10 mg/kg/Day Dose-ITT Analysis Set Placebo-ITT Analysis Set Total
Hide Arm/Group Description Participants received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement; analyzed according to the treatment group to which they were randomized (GWP42003-P 20 mg/kg/day). Participants received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement; analyzed according to the treatment group to which they were randomized (GWP42003-P 10 mg/kg/day). Participants received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement; analyzed according to the treatment group to which they were randomized (Placebo). Total of all reporting groups
Overall Number of Baseline Participants 76 73 76 225
Hide Baseline Analysis Population Description
ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 73 participants 76 participants 225 participants
16.0  (10.8) 15.4  (9.5) 15.3  (9.3) 15.6  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 73 participants 76 participants 225 participants
Female
31
  40.8%
33
  45.2%
32
  42.1%
96
  42.7%
Male
45
  59.2%
40
  54.8%
44
  57.9%
129
  57.3%
1.Primary Outcome
Title Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period
Hide Description Drop seizures were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Drop seizures were defined as the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in the IVRS. 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). Negative percentages show an improvement from baseline.
Time Frame Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.
Arm/Group Title GWP42003-P 20 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose Placebo
Hide Arm/Group Description:
Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
Participants received placebo (0 mg/mL CBD), volume matched to 1 of the 2 dose levels (10 or 20 mg/kg/day), administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 7 to 11 days according to the matched IMP group (7 or 11 days for the 10 or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day of the matched dose) period.
Overall Number of Participants Analyzed 76 73 76
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-41.86
(-72.4 to -1.3)
-37.16
(-63.8 to -5.6)
-17.17
(-37.1 to 0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GWP42003-P 20 mg/kg/Day Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0047
Comments [Not Specified]
Method Wilcoxon rank-sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -21.57
Confidence Interval (2-Sided) 95%
-34.79 to -6.67
Estimation Comments Calculated using the Hodges-Lehmann approach
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GWP42003-P 10 mg/kg/Day Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0016
Comments [Not Specified]
Method Wilcoxon rank-sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -19.19
Confidence Interval (2-Sided) 95%
-31.24 to -7.69
Estimation Comments Calculated using the Hodges-Lehmann approach
2.Secondary Outcome
Title Number Of Participants With A ≥50% Reduction From Baseline In Drop Seizure Frequency During The Treatment Period
Hide Description Drop seizures were recorded by the participant or caregiver using an IVRS diary. Drop seizures included the subset of tonic-clonic, tonic, or atonic seizures that were reported as drop seizures in IVRS. Percentage change from baseline was calculated as per the primary outcome measure.
Time Frame Baseline to EOT (Day 99) or ET
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.
Arm/Group Title GWP42003-P 20 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose Placebo
Hide Arm/Group Description:
Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
Participants received placebo (0 mg/mL CBD), volume matched to 1 of the 2 dose levels (10 or 20 mg/kg/day), administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 7 to 11 days according to the matched IMP group (7 or 11 days for the 10 or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day of the matched dose) period.
Overall Number of Participants Analyzed 76 73 76
Measure Type: Count of Participants
Unit of Measure: Participants
30
  39.5%
26
  35.6%
11
  14.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GWP42003-P 20 mg/kg/Day Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments Calculated using a Cochran-Mantel-Haenszel (CMH) test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.85
Confidence Interval (2-Sided) 95%
1.75 to 8.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GWP42003-P 10 mg/kg/Day Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0030
Comments Calculated using a CMH test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.27
Confidence Interval (2-Sided) 95%
1.47 to 7.26
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period
Hide Description Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. Negative percentages show an improvement from baseline.
Time Frame Baseline to EOT (Day 99) or ET
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.
Arm/Group Title GWP42003-P 20 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose Placebo
Hide Arm/Group Description:
Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
Participants received placebo (0 mg/mL CBD), volume matched to 1 of the 2 dose levels (10 or 20 mg/kg/day), administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 7 to 11 days according to the matched IMP group (7 or 11 days for the 10 or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day of the matched dose) period.
Overall Number of Participants Analyzed 76 73 76
Median (Inter-Quartile Range)
Unit of Measure: percentage change
-38.40
(-64.6 to -0.7)
-36.44
(-64.5 to -10.8)
-18.47
(-39.0 to 0.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GWP42003-P 20 mg/kg/Day Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0091
Comments [Not Specified]
Method Wilcoxon rank-sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -18.76
Confidence Interval (2-Sided) 95%
-31.80 to -4.43
Estimation Comments Calculated using the Hodges-Lehmann approach
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GWP42003-P 10 mg/kg/Day Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0015
Comments [Not Specified]
Method Wilcoxon rank-sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -19.47
Confidence Interval (2-Sided) 95%
-30.37 to -7.47
Estimation Comments Calculated using the Hodges-Lehmann approach
4.Secondary Outcome
Title Subject/Caregiver Global Impression Of Change (S/CGIC) Assessment
Hide Description The S/CGIC was used to assess the participant's overall condition on a 7-point scale, using the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse" (1 = very much improved; 7 = very much worse). On Day 1 (prior to starting IMP), the caregiver was asked to write a brief description of the participant's overall condition as a memory aid for the S/CGIC questionnaire at subsequent visits. If both a CGIC and SGIC were completed then the CGIC was used; if only a CGIC was completed then the CGIC was used; if only a SGIC was completed then the SGIC was used. Last visit for endpoints assessed at clinic visits was defined as the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant's last evaluation was performed.
Time Frame Baseline to Last Visit (Day 99) or ET
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.
Arm/Group Title GWP42003-P 20 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose Placebo
Hide Arm/Group Description:
Participants received GWP42003-P 20 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 20 mg/kg/day over 11 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
Participants received GWP42003-P 10 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 10 mg/kg/day over 7 days and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day) period.
Participants received placebo (0 mg/mL CBD), volume matched to 1 of the 2 dose levels (10 or 20 mg/kg/day), administered orally, half in the morning and half in the evening. To maintain the blinded aspect of the study, participants titrated the placebo dose over 7 to 11 days according to the matched IMP group (7 or 11 days for the 10 or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the 12-week maintenance period. If the participant did not immediately enter the OLE study, the maintenance period was followed by a 10-day taper (10% per day of the matched dose) period.
Overall Number of Participants Analyzed 75 73 75
Measure Type: Count of Participants
Unit of Measure: Participants
Very Much Improved
6
   8.0%
9
  12.3%
1
   1.3%
Much Improved
15
  20.0%
14
  19.2%
8
  10.7%
Slightly Improved
22
  29.3%
25
  34.2%
24
  32.0%
No Change
25
  33.3%
21
  28.8%
35
  46.7%
Slightly Worse
6
   8.0%
3
   4.1%
4
   5.3%
Much Worse
1
   1.3%
1
   1.4%
3
   4.0%
Very Much Worse
0
   0.0%
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GWP42003-P 20 mg/kg/Day Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0439
Comments [Not Specified]
Method Regression, Logistic
Comments Ordinal logistic regression model with treatment group as a fixed factor
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.83
Confidence Interval (2-Sided) 95%
1.02 to 3.30
Estimation Comments Odds of participant recording a lower score (improvement) on a continuous scale
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GWP42003-P 10 mg/kg/Day Dose, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments [Not Specified]
Method Regression, Logistic
Comments Ordinal logistic regression model with treatment group as a fixed factor
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.57
Confidence Interval (2-Sided) 95%
1.41 to 4.66
Estimation Comments Odds of participant recording a lower score (improvement) on a continuous scale
Time Frame Day 1 through Day 137 (Safety Follow-up)
Adverse Event Reporting Description Safety Analysis Set: Received at least 1 dose of IMP; analyzed as per actual treatment received. Six participants who were assigned to the GWP42003-P 10 mg/kg/day dose received dosing schedules for GWP42003-P 20 mg/kg/day. For safety analyses, these participants were assigned to the GWP42003-P 20 mg/kg/day group.
 
Arm/Group Title GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set Placebo-Safety Analysis Set
Hide Arm/Group Description Participants received at least 1 dose of IMP; analyzed as per actual treatment received. Six participants who were assigned to the GWP42003-P 10 mg/kg/day dose received dosing schedules for GWP42003-P 20 mg/kg/day. For safety analyses, these participants were assigned to the GWP42003-P 20 mg/kg/day group. Participants received at least 1 dose of IMP; analyzed as per actual treatment received. Six participants who were assigned to the GWP42003-P 10 mg/kg/day dose received dosing schedules for GWP42003-P 20 mg/kg/day. For safety analyses, these participants were assigned to the GWP42003-P 20 mg/kg/day group. Participants received at least 1 dose of IMP; analyzed as per actual treatment received.
All-Cause Mortality
GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set Placebo-Safety Analysis Set
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set Placebo-Safety Analysis Set
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/82 (15.85%)   13/67 (19.40%)   8/76 (10.53%) 
Blood and lymphatic system disorders       
Lymphopenia † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Gastrointestinal disorders       
Constipation † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Pneumatosis intestinalis † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Pancreatitis † 1  0/82 (0.00%)  1/67 (1.49%)  0/76 (0.00%) 
Faecaloma † 1  0/82 (0.00%)  0/67 (0.00%)  1/76 (1.32%) 
General disorders       
Device malfunction † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Pyrexia † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Hepatobiliary disorders       
Cholecystitis chronic † 1  0/82 (0.00%)  1/67 (1.49%)  0/76 (0.00%) 
Infections and infestations       
Pneumonia † 1  2/82 (2.44%)  3/67 (4.48%)  0/76 (0.00%) 
Adenovirus infection † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Pneumonia mycoplasmal † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Respiratory syncytial virus infection † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Upper respiratory tract infection † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Pneumonia bacterial † 1  0/82 (0.00%)  1/67 (1.49%)  0/76 (0.00%) 
Pneumonia respiratory syncytial viral † 1  0/82 (0.00%)  1/67 (1.49%)  0/76 (0.00%) 
Tracheobronchitis † 1  0/82 (0.00%)  0/67 (0.00%)  1/76 (1.32%) 
Injury, poisoning and procedural complications       
Delayed recovery from anaesthesia † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Investigations       
Aspartate aminotransferase increased † 1  1/82 (1.22%)  1/67 (1.49%)  0/76 (0.00%) 
Alanine aminotransferase increased † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Gamma-glutamyltransferase increased † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Transaminases increased † 1  0/82 (0.00%)  1/67 (1.49%)  0/76 (0.00%) 
Investigation † 1  0/82 (0.00%)  0/67 (0.00%)  1/76 (1.32%) 
Metabolism and nutrition disorders       
Dehydration † 1  0/82 (0.00%)  1/67 (1.49%)  0/76 (0.00%) 
Nervous system disorders       
Status epilepticus † 1  4/82 (4.88%)  7/67 (10.45%)  3/76 (3.95%) 
Convulsion † 1  2/82 (2.44%)  0/67 (0.00%)  0/76 (0.00%) 
Lethargy † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Somnolence † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Sedation † 1  0/82 (0.00%)  1/67 (1.49%)  0/76 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis † 1  0/82 (0.00%)  0/67 (0.00%)  1/76 (1.32%) 
Respiratory, thoracic and mediastinal disorders       
Pleural effusion † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
Hypoxia † 1  0/82 (0.00%)  1/67 (1.49%)  1/76 (1.32%) 
Hypoventilation † 1  0/82 (0.00%)  1/67 (1.49%)  0/76 (0.00%) 
Sleep apnoea syndrome † 1  0/82 (0.00%)  1/67 (1.49%)  0/76 (0.00%) 
Vascular disorders       
Hypotension † 1  1/82 (1.22%)  0/67 (0.00%)  0/76 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GWP42003-P 20 mg/kg/Day Dose-Safety Analysis Set GWP42003-P 10 mg/kg/Day Dose-Safety Analysis Set Placebo-Safety Analysis Set
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   63/82 (76.83%)   36/67 (53.73%)   40/76 (52.63%) 
Gastrointestinal disorders       
Diarrhoea † 1  12/82 (14.63%)  7/67 (10.45%)  6/76 (7.89%) 
Vomiting † 1  10/82 (12.20%)  4/67 (5.97%)  9/76 (11.84%) 
General disorders       
Pyrexia † 1  9/82 (10.98%)  6/67 (8.96%)  12/76 (15.79%) 
Fatigue † 1  8/82 (9.76%)  5/67 (7.46%)  2/76 (2.63%) 
Infections and infestations       
Upper respiratory tract infection † 1  10/82 (12.20%)  11/67 (16.42%)  11/76 (14.47%) 
Nasopharyngitis † 1  9/82 (10.98%)  3/67 (4.48%)  5/76 (6.58%) 
Metabolism and nutrition disorders       
Decreased appetite † 1  21/82 (25.61%)  11/67 (16.42%)  6/76 (7.89%) 
Nervous system disorders       
Somnolence † 1  25/82 (30.49%)  14/67 (20.90%)  4/76 (5.26%) 
Lethargy † 1  5/82 (6.10%)  3/67 (4.48%)  2/76 (2.63%) 
Convulsion † 1  5/82 (6.10%)  2/67 (2.99%)  7/76 (9.21%) 
Headache † 1  5/82 (6.10%)  2/67 (2.99%)  3/76 (3.95%) 
Psychiatric disorders       
Irritability † 1  4/82 (4.88%)  6/67 (8.96%)  2/76 (2.63%) 
Insomnia † 1  4/82 (4.88%)  4/67 (5.97%)  2/76 (2.63%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
[Not Specified]
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
EMail: medinfo@gwpharm.com, medinfo@greenwichbiosciences.com
Publications of Results:
Devinsky O, Patel AD, Cross JH, Villanueva V, Wirrell EC, Privitera M, Greenwood SM, Roberts C, Checketts D, VanLandingham KE, Zuberi SM; GWPCARE3 Study Group. Effect of Cannabidiol on Drop Seizures in the Lennox-Gastaut Syndrome. N Engl J Med. 2018 May 17;378(20):1888-1897. doi: 10.1056/NEJMoa1714631.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02224560    
Other Study ID Numbers: GWEP1414
2014-002940-42 ( EudraCT Number )
First Submitted: August 21, 2014
First Posted: August 25, 2014
Results First Submitted: June 25, 2018
Results First Posted: July 27, 2018
Last Update Posted: September 28, 2022