Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)

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: NCT02091206
Recruitment Status : Completed
First Posted : March 19, 2014
Results First Posted : July 19, 2018
Last Update Posted : August 24, 2018
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 5 mg/kg/day Dose
Drug: Placebo control
Drug: GWP42003-P 10 mg/kg/day Dose
Drug: GWP42003-P 20 mg/kg/day Dose
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GWP42003-P 5 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose GWP42003-P 20 mg/kg/Day Dose Placebo
Hide Arm/Group Description Participants received GWP42003-P 5 milligrams (mg) per kilogram (kg) per day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment 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 rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. 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 rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. Participants received placebo (0 mg/milliliter [mL] cannabidiol [CBD]), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched investigational medicinal product (IMP) group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
Period Title: Treatment Period
Started 10 8 9 7
Safety Analysis Set [1] 10 8 9 7
Completed 10 7 8 7
Not Completed 0 1 1 0
Reason Not Completed
Adverse Event             0             1             0             0
Met withdrawal criteria             0             0             1             0
[1]
All randomized participants who received at least 1 dose of IMP
Period Title: Taper Period
Started 10 7 8 7
Completed 9 7 8 5
Not Completed 1 0 0 2
Reason Not Completed
Participant refused study drug             1             0             0             1
Lost to Follow-up             0             0             0             1
Arm/Group Title GWP42003-P 5 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose GWP42003-P 20 mg/kg/Day Dose Placebo Total
Hide Arm/Group Description Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment 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 rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. 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 rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period. Total of all reporting groups
Overall Number of Baseline Participants 10 8 9 7 34
Hide Baseline Analysis Population Description
Safety Analysis Set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 8 participants 9 participants 7 participants 34 participants
7.150  (1.8955) 7.368  (2.1229) 8.671  (1.7957) 6.978  (0.9476) 7.568  (1.8300)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 9 participants 7 participants 34 participants
Female
5
  50.0%
5
  62.5%
6
  66.7%
2
  28.6%
18
  52.9%
Male
5
  50.0%
3
  37.5%
3
  33.3%
5
  71.4%
16
  47.1%
1.Primary Outcome
Title Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)
Hide Description

A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of IMP. If an AE had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of IMP then the AE was considered a TEAE. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through the Safety Follow-up Visit (Day 60) is presented.

A summary of serious and all other non-serious AEs regardless of causality is located in the Adverse Events module.

Time Frame Baseline (Day 1) through Safety follow-up visit (Day 60)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.
Arm/Group Title GWP42003-P 5 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose GWP42003-P 20 mg/kg/Day Dose Placebo
Hide Arm/Group Description:
Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment 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 rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
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 rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
Overall Number of Participants Analyzed 10 8 9 7
Measure Type: Count of Participants
Unit of Measure: Participants
2
  20.0%
1
  12.5%
0
   0.0%
1
  14.3%
2.Secondary Outcome
Title Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22
Hide Description AUC0-t for CBD and its major metabolites, 6-hydroxy-CBD (6-OH-CBD), 7-hydroxy-CBD (7-OH-CBD), and 7-carboxy-CBD (7-COOH-CBD) were calculated using blood samples collected before and after IMP dosing on Days 1 and 22. One sample was collected predose, 2 to 3 hours postdose, and 4 to 6 hours postdose for CBD and its metabolites. Results are presented for participants who received GWP42003-P at 5, 10, or 20 mg/kg/day during the study and for participants with a numeric result for the given evaluation.
Time Frame Predose and 2-6 hours postdose on Days 1 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.
Arm/Group Title GWP42003-P 5 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose GWP42003-P 20 mg/kg/Day Dose
Hide Arm/Group Description:
Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment 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 rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
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 rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
Overall Number of Participants Analyzed 10 8 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours * nanograms/mL
Day 1 CBD Number Analyzed 5 participants 7 participants 7 participants
70.61
(20.38%)
66.35
(120.8%)
73.69
(96.64%)
Day 22 CBD Number Analyzed 9 participants 7 participants 7 participants
240.8
(100.8%)
721.8
(79.92%)
962.6
(93.43%)
Day 1 6-OH-CBD Number Analyzed 3 participants 5 participants 5 participants
3.27
(132%)
2.79
(87.7%)
5.16
(57.2%)
Day 22 6-OH-CBD Number Analyzed 8 participants 7 participants 6 participants
9.33
(119%)
26.3
(82.9%)
58.6
(90.1%)
Day 1 7-OH-CBD Number Analyzed 5 participants 7 participants 8 participants
21.9
(57.0%)
18.4
(299%)
30.2
(105%)
Day 22 7-OH-CBD Number Analyzed 8 participants 7 participants 6 participants
131
(107%)
244
(120%)
508
(96.0%)
Day 1 7-COOH-CBD Number Analyzed 6 participants 6 participants 6 participants
297
(97.3%)
125
(1750%)
195
(573%)
Day 22 7-COOH-CBD Number Analyzed 9 participants 5 participants 5 participants
4190
(81.20%)
9220
(178%)
15500
(148%)
3.Secondary Outcome
Title Mean Percentage Change From Baseline To End Of Treatment In Plasma Clobazam (CLB) And N-Desmethylclobazam (N-CLB) Concentrations
Hide Description Plasma concentrations of CLB and N-CLB were measured on Days 1 and 22. Participants were instructed to take their daily dose of CLB 2 hours prior to the anticipated pre-IMP blood specimen collection on both days. Blood samples were collected prior to administration of IMP. Results are presented for a subgroup of participants who took CLB during the study and had PK samples analyzed at both PK sampling visits (Days 1 and 22).
Time Frame Predose on Days 1 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.
Arm/Group Title GWP42003-P 5 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose GWP42003-P 20 mg/kg/Day Dose Placebo
Hide Arm/Group Description:
Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment 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 rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
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 rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period.
Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
Overall Number of Participants Analyzed 6 6 5 5
Measure Type: Number
Unit of Measure: percent change
% change in CLB -1.2 18.0 29.6 15.1
% change in N-CLB 258.7 170.7 228.9 -5.6
Time Frame Up to Day 60
Adverse Event Reporting Description All participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.
 
Arm/Group Title GWP42003-P 5 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose GWP42003-P 20 mg/kg/Day Dose Placebo
Hide Arm/Group Description Participants received GWP42003-P 5 mg/kg/day administered orally, half in the morning and half in the evening. Participants titrated GWP42003-P to 5 mg/kg/day over 3 days and remained at this dose for the rest of the 21-day treatment period (19 days). The 21-day treatment 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 rest of the 21-day treatment period (15 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. 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 rest of the 21-day treatment period (11 days). The 21-day treatment period was followed by a 10-day taper (10% per day) period. Participants received placebo (0 mg/mL CBD), volume matched to one of the 3 dose levels (5, 10, or 20 mg/kg/day), administered orally, half in the morning and half in the evening for 21 days. To maintain the blinded aspect of the study, participants titrated the placebo dose over 3 to 11 days according to the matched IMP group (3, 7, and 11 days for the 5, 10, or 20 mg/kg/day GWP42003-P groups, respectively) and remained at this dose for the rest of the 21-day treatment period. The 21-day treatment period was followed by a 10-day taper (10% per day of the matched dose) period.
All-Cause Mortality
GWP42003-P 5 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose GWP42003-P 20 mg/kg/Day Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GWP42003-P 5 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose GWP42003-P 20 mg/kg/Day Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/10 (10.00%)   2/8 (25.00%)   1/9 (11.11%)   1/7 (14.29%) 
General disorders         
Pyrexia  1  0/10 (0.00%)  2/8 (25.00%)  0/9 (0.00%)  0/7 (0.00%) 
Infections and infestations         
Parvovirus Infection  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Viral Infection  1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Nervous system disorders         
Convulsion  1  0/10 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  1/7 (14.29%) 
Status Epilepticus  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash Maculo-papular  1  0/10 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/7 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GWP42003-P 5 mg/kg/Day Dose GWP42003-P 10 mg/kg/Day Dose GWP42003-P 20 mg/kg/Day Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/10 (80.00%)   5/8 (62.50%)   7/9 (77.78%)   6/7 (85.71%) 
Eye disorders         
Diplopia  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Gastrointestinal disorders         
Abdominal Pain Upper  1  0/10 (0.00%)  0/8 (0.00%)  2/9 (22.22%)  0/7 (0.00%) 
Constipation  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Diarrhoea  1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Dry Mouth  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Eructation  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Haematochezia  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Vomiting  1  1/10 (10.00%)  1/8 (12.50%)  1/9 (11.11%)  0/7 (0.00%) 
General disorders         
Fatigue  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  2/7 (28.57%) 
Gait disturbance  1  0/10 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/7 (0.00%) 
Influenza like illness  1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Pyrexia  1  3/10 (30.00%)  1/8 (12.50%)  0/9 (0.00%)  0/7 (0.00%) 
Infections and infestations         
Erythema infectiosum  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Gastroenteritis  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  2/7 (28.57%) 
Gastroenteritis viral  1  1/10 (10.00%)  0/8 (0.00%)  1/9 (11.11%)  1/7 (14.29%) 
Lower respiratory tract infection  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Nasopharyngitis  1  0/10 (0.00%)  1/8 (12.50%)  1/9 (11.11%)  1/7 (14.29%) 
Otitis media acute  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Pharyngitis streptococcal  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Pneumonia  1  0/10 (0.00%)  1/8 (12.50%)  1/9 (11.11%)  0/7 (0.00%) 
Upper respiratory tract infection  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Viral infection  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Viral rash  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Injury, poisoning and procedural complications         
Accident  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Investigations         
Aspartate aminotransferase increased  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Electrocardiogram QT prolonged  1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Hepatic enzyme increased  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Liver function test abnormal  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Urine ketone body absent  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Urine ketone body present  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  0/10 (0.00%)  1/8 (12.50%)  4/9 (44.44%)  0/7 (0.00%) 
Increased appetite  1  0/10 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/7 (0.00%) 
Ketosis  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Nervous system disorders         
Ataxia  1  2/10 (20.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Convulsion  1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Coordination abnormal  1  0/10 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/7 (0.00%) 
Dysarthria  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Headache  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Poor quality sleep  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Psychomotor hyperactivity  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Sedation  1  2/10 (20.00%)  0/8 (0.00%)  2/9 (22.22%)  0/7 (0.00%) 
Somnolence  1  2/10 (20.00%)  3/8 (37.50%)  0/9 (0.00%)  1/7 (14.29%) 
Tremor  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Psychiatric disorders         
Abnormal behaviour  1  3/10 (30.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Irritability  1  0/10 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/7 (0.00%) 
Mood swings  1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Renal and urinary disorders         
Proteinuria  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Skin and subcutaneous tissue disorders         
Dermatitis diaper  1  0/10 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/7 (14.29%) 
Erythema  1  1/10 (10.00%)  0/8 (0.00%)  0/9 (0.00%)  0/7 (0.00%) 
Rash  1  0/10 (0.00%)  1/8 (12.50%)  1/9 (11.11%)  0/7 (0.00%) 
Rash papular  1  0/10 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/7 (0.00%) 
Urticaria  1  0/10 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/7 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Analytical issues for 7-OH-CBD related to reference material batch used during analysis. Data are qualitative.
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
Name/Title: Medical Enquires
Organization: GW Research Ltd.
Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT02091206     History of Changes
Other Study ID Numbers: GWEP1332 Part A
2014-002941-23 ( EudraCT Number )
First Submitted: March 17, 2014
First Posted: March 19, 2014
Results First Submitted: June 25, 2018
Results First Posted: July 19, 2018
Last Update Posted: August 24, 2018