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Trial record 18 of 56 for:    insys

Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders

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: NCT02324673
Recruitment Status : Completed
First Posted : December 24, 2014
Results First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Seizures
Intervention Drug: Cannabidiol Oral Solution
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10. Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10. High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Period Title: Overall Study
Started 20 20 21
Completed 20 20 21
Not Completed 0 0 0
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day] Total
Hide Arm/Group Description Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10. Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10. High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10. Total of all reporting groups
Overall Number of Baseline Participants 20 20 21 61
Hide Baseline Analysis Population Description
Safety Analysis Population (SAF), all participants who received ≥1 dose of the investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 21 participants 61 participants
7.5  (5.32) 7.7  (5.17) 7.8  (5.39) 7.6  (5.21)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 21 participants 61 participants
Infants = 1 to <2 years
5
  25.0%
5
  25.0%
5
  23.8%
15
  24.6%
Children = 2 to <12 years
9
  45.0%
9
  45.0%
10
  47.6%
28
  45.9%
Adolescents = 12 to ≤17 years
6
  30.0%
6
  30.0%
6
  28.6%
18
  29.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 21 participants 61 participants
Female
10
  50.0%
7
  35.0%
11
  52.4%
28
  45.9%
Male
10
  50.0%
13
  65.0%
10
  47.6%
33
  54.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 21 participants 61 participants
20
 100.0%
20
 100.0%
21
 100.0%
61
 100.0%
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population (PK), all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: nanograms/milliliter (ng/mL)
Cannabidiol 59.03  (99.98) 110.5  (142.3) 256.9  (351.9)
7-OH Cannabidiol 28.71  (26.72) 61.89  (72.88) 140.9  (210.0)
2.Primary Outcome
Title Cmax for Cannabidiol and Metabolite 7-OH Cannabidiol
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.

Time Frame Day 10 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cannabidiol Number Analyzed 20 participants 17 participants 21 participants
119.6  (105.0) 220.0  (294.7) 426.8  (327.7)
7-OH Cannabidiol Number Analyzed 20 participants 17 participants 21 participants
79.38  (40.82) 136.6  (140.9) 286.1  (201.9)
3.Primary Outcome
Title Dose Normalized Cmax (Cmax/D) for Cannabidiol and Metabolite 7-OH Cannabidiol
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: ng/mL/(mg/kg)
Cannabidiol 11.72  (19.89) 10.77  (13.97) 13.25  (18.07)
7-OH Cannabidiol 5.737  (5.330) 5.990  (7.011) 7.286  (10.91)
4.Primary Outcome
Title Cmax/D for Cannabidiol and Metabolite 7-OH Cannabidiol
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.

Time Frame Day 10 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: ng/mL/(mg/kg)
Cannabidiol Number Analyzed 20 participants 17 participants 21 participants
23.79  (20.46) 21.16  (28.40) 21.40  (16.38)
7-OH Cannabidiol Number Analyzed 20 participants 17 participants 21 participants
15.82  (7.928) 13.10  (13.06) 14.39  (10.26)
5.Primary Outcome
Title Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for tmax.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Median (Full Range)
Unit of Measure: hours (h)
Cannabidiol
2.58
(1.02 to 8.00)
4.00
(1.00 to 8.08)
3.15
(1.00 to 24.02)
7-OH Cannabidiol
2.55
(1.00 to 6.08)
4.00
(1.00 to 11.95)
3.07
(1.00 to 12.05)
6.Primary Outcome
Title Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.

Time Frame Day 10 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for tmax.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Median (Full Range)
Unit of Measure: h
Cannabidiol Number Analyzed 20 participants 17 participants 21 participants
2.99
(1.00 to 4.25)
2.00
(0.00 to 6.00)
3.00
(0.00 to 6.02)
7-OH Cannabidiol Number Analyzed 20 participants 17 participants 21 participants
2.08
(1.00 to 4.08)
2.03
(1.00 to 6.05)
2.03
(0.00 to 5.90)
7.Primary Outcome
Title Half Life (t1/2) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for t1/2.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 15 15 16
Mean (Standard Deviation)
Unit of Measure: h
Cannabidiol Number Analyzed 11 participants 8 participants 12 participants
31.31  (23.46) 33.48  (14.97) 21.58  (10.50)
7-OH Cannabidiol Number Analyzed 15 participants 13 participants 13 participants
19.71  (7.640) 31.84  (24.28) 14.77  (4.354)
8.Primary Outcome
Title Elimination Rate (Lambda-z [λz]) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for λz.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 15 15 16
Mean (Standard Deviation)
Unit of Measure: 1/h
Cannabidiol Number Analyzed 11 participants 8 participants 12 participants
0.02969  (0.01386) 0.02836  (0.02340) 0.03949  (0.01976)
7-OH Cannabidiol Number Analyzed 15 participants 13 participants 13 participants
0.04053  (0.01557) 0.03276  (0.01985) 0.05123  (0.01711)
9.Primary Outcome
Title Oral Clearance (CL/F) for Cannabidiol for Participants ≥2 Years of Age
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for CL/F.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 10 8 12
Mean (Standard Deviation)
Unit of Measure: Liters (L)/h/kg
29.78  (15.96) 21.10  (23.04) 31.29  (30.43)
10.Primary Outcome
Title Volume of Distribution (Vz/F) of Cannabidiol for Participants ≥2 Years of Age
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Vz/F.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 10 8 12
Mean (Standard Deviation)
Unit of Measure: L/kg
1021  (609.1) 930.8  (1034) 982.6  (1119)
11.Primary Outcome
Title Area Under the Plasma-Concentration Time Curve From 0 to 12 Hours Post-dose [AUC(0-12)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12).
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
Cannabidiol Number Analyzed 20 participants 19 participants 21 participants
173.9  (179.6) 507.1  (687.7) 914.5  (1155)
7-OH Cannabidiol Number Analyzed 20 participants 19 participants 21 participants
124.4  (80.18) 329.8  (402.9) 646.7  (886.3)
12.Primary Outcome
Title Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12)/D.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
Cannabidiol Number Analyzed 20 participants 19 participants 21 participants
34.60  (35.48) 49.23  (66.68) 47.13  (59.38)
7-OH Cannabidiol Number Analyzed 20 participants 19 participants 21 participants
24.88  (15.93) 31.77  (38.00) 33.39  (45.94)
13.Primary Outcome
Title AUC From Time 0 to the Last Quantifiable Concentration [AUC(0-last)] on Day 1 for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-last).
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 15 15 16
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
Cannabidiol 250.0  (217.1) 692.5  (826.9) 1355  (1447)
7-OH Cannabidiol 212.2  (112.1) 544.9  (526.6) 1221  (1296)
14.Primary Outcome
Title AUC From Time 0 to Infinity [AUC(0-inf)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-inf).
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 15 15 16
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
Cannabidiol Number Analyzed 10 participants 8 participants 12 participants
270.1  (256.7) 1140  (1118) 1584  (1709)
7-OH Cannabidiol Number Analyzed 15 participants 11 participants 13 participants
229.3  (122.3) 704.1  (627.8) 1354  (1428)
15.Primary Outcome
Title Dose Normalized AUC(0-inf) [AUC(0-inf)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-inf)/D.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 15 15 16
Mean (Standard Deviation)
Unit of Measure: ng*h/mL/(mg/kg)
Cannabidiol Number Analyzed 10 participants 8 participants 12 participants
53.64  (50.04) 111.8  (111.2) 83.10  (87.93)
7-OH Cannabidiol Number Analyzed 15 participants 11 participants 13 participants
46.07  (24.63) 68.43  (62.34) 70.34  (73.66)
16.Primary Outcome
Title Metabolite (7-OH Cannabidiol) to Parent (Cannabidiol) Ratio for Cmax [MRCmax] on Day 1
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.

MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRCmax.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: ratio
0.8935  (0.5543) 0.9328  (0.8332) 0.8081  (0.4849)
17.Primary Outcome
Title MRCmax on Day 10
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.

MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).

Time Frame Day 10 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for metabolite to parent ratio.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 17 21
Mean (Standard Deviation)
Unit of Measure: ratio
0.7717  (0.3960) 0.8230  (0.3880) 0.7657  (0.4179)
18.Primary Outcome
Title Metabolite to Parent Ratio for AUC(0-inf) [MRAUC(0-inf)] on Day 1 for Participants ≥2 Years of Age
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.

MRAUC(0-inf) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-inf).
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 10 8 12
Mean (Standard Deviation)
Unit of Measure: ratio
0.9099  (0.5173) 0.9459  (0.4874) 0.9538  (0.4370)
19.Primary Outcome
Title Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 1
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.

MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).

Time Frame Day 1 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-12).
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 19 21
Mean (Standard Deviation)
Unit of Measure: ratio
0.9309  (0.5229) 0.9793  (0.7147) 0.9085  (0.5075)
20.Primary Outcome
Title Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 10
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.

MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).

Time Frame Day 10 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-12).
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 19 17 21
Mean (Standard Deviation)
Unit of Measure: ratio
0.8795  (0.4084) 0.7866  (0.2361) 0.8700  (0.4304)
21.Primary Outcome
Title AUC(0-12) for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.

Time Frame Day 10 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12).
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
Cannabidiol Number Analyzed 19 participants 17 participants 21 participants
581.6  (283.4) 1098  (976.4) 2708  (1789)
7-OH Cannabidiol Number Analyzed 19 participants 17 participants 21 participants
513.4  (269.0) 832.8  (675.2) 2165  (1405)
22.Primary Outcome
Title Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.

Time Frame Day 10 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12)/D.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: ng*h/mL/(mg/kg)
Cannabidiol Number Analyzed 19 participants 17 participants 21 participants
115.8  (55.32) 106.0  (94.64) 135.7  (89.17)
7-OH Cannabidiol Number Analyzed 19 participants 17 participants 21 participants
102.2  (53.01) 80.19  (63.53) 108.7  (70.76)
23.Primary Outcome
Title Minimum Plasma Concentration (Cmin) for Cannabidiol and Metabolite 7-OH Cannabidiol
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.

Time Frame Day 10 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmin.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cannabidiol Number Analyzed 19 participants 17 participants 21 participants
19.97  (8.798) 41.67  (25.41) 118.3  (75.82)
7-OH Cannabidiol Number Analyzed 19 participants 17 participants 21 participants
21.82  (13.23) 34.11  (23.99) 108.7  (70.87)
24.Primary Outcome
Title Average Plasma Concentration (Cavg) for Cannabidiol and Metabolite 7-OH Cannabidiol
Hide Description

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.

Time Frame Day 10 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cavg.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cannabidiol Number Analyzed 19 participants 17 participants 21 participants
48.56  (23.58) 91.38  (80.92) 225.7  (149.3)
7-OH Cannabidiol Number Analyzed 19 participants 17 participants 21 participants
42.94  (22.54) 69.37  (56.09) 180.4  (117.1)
25.Primary Outcome
Title Accumulation Ratio for Cmax (RCmax) on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol
Hide Description

RCmax is the ratio of Cmax at Day 10 compared to Cmax at Day 1.

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.

Time Frame Day 10 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for RCmax.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: ratio
Cannabidiol Number Analyzed 20 participants 17 participants 21 participants
5.535  (5.551) 4.454  (4.466) 7.488  (11.93)
7-OH Cannabidiol Number Analyzed 20 participants 17 participants 21 participants
3.823  (2.730) 3.996  (3.544) 5.788  (6.028)
26.Primary Outcome
Title Accumulation Ratio for AUC(0-12) [RAUC(0-12)] on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol
Hide Description

RAUC(0-12) is the ratio of AUC(0-12) at Day 10 compared to AUC(0-12) at Day 1.

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.

Time Frame Day 10 at age-specific times
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for RAUC(0-12).
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: ratio
Cannabidiol Number Analyzed 19 participants 17 participants 21 participants
5.434  (3.625) 5.489  (4.633) 9.376  (15.11)
7-OH Cannabidiol Number Analyzed 19 participants 17 participants 21 participants
4.865  (2.748) 4.524  (3.338) 7.541  (7.187)
27.Primary Outcome
Title Time Linearity Index for Cannabidiol and Metabolite 7-OH Cannabidiol in Participants ≥2 Years of Age
Hide Description

Time linearity index is calculated as the ratio of AUC(0-12) on Day 10/AUC[0-inf] on Day 1.

Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:

Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.

Time Frame Day 1 and Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for time linearity index.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 15 15 16
Mean (Standard Deviation)
Unit of Measure: ratio
Cannabidiol Number Analyzed 9 participants 6 participants 12 participants
3.211  (2.048) 2.628  (2.276) 4.201  (4.990)
7-OH Cannabidiol Number Analyzed 14 participants 9 participants 13 participants
2.500  (0.9365) 1.821  (1.162) 3.045  (2.260)
28.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event not present prior to the initiation of the treatment or any event already present that worsens. Any laboratory (clinical chemistry, hematology, urinalysis), 12-lead electrocardiograms, vital signs (temperature, blood pressure, pulse rate, respiratory rate) and physical examination findings deemed by the investigator to be clinically significant were captured as AEs. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires the participant be at a risk of death at the time of the event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or other serious event that requires medical or surgical intervention.
Time Frame From the first dose of study drug up to Day 17
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Hide Analysis Population Description
Safety Analysis Population (SAF), all participants who received ≥1 dose of the investigational product.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE
13
  65.0%
9
  45.0%
17
  81.0%
SAE
0
   0.0%
1
   5.0%
2
   9.5%
29.Primary Outcome
Title Clinical Global Impression of Improvement (CGI-I) Assessment
Hide Description The CGI-I was completed by the parents/caregivers and the investigator and was used to assess participants global status of their condition on Day 11 using a 7-point scale, where 1=very much improved and 7=very much worse since the initiation of treatment.
Time Frame Day 11
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Hide Analysis Population Description
Efficacy Analysis Population (EFF), all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for CGI-I post-dose.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Parents/Caregivers 2.1  (1.02) 2.4  (0.82) 2.3  (1.15)
Investigator 2.7  (0.92) 2.5  (0.94) 2.9  (0.91)
30.Primary Outcome
Title Change From Baseline in Clinical Global Impression of Severity (CGI-S) Assessment
Hide Description The CGI-S was completed by the parents/caregivers and the Investigator and was used to rate participant’s mental illness status at Baseline (Screening) and Day 11 using a 7-point scale, where 1=normal, not mentally ill, and 7=among the most extremely mentally ill participants. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. The change in CGI-S score at Day 11 relative to Baseline is reported. A negative change from Baseline indicates improvement (decreased severity in illness).
Time Frame Baseline and Day 11
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Hide Analysis Population Description
EFF, all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for CGI-S post-dose.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Parents/Caregivers Number Analyzed 17 participants 19 participants 21 participants
-1.7  (2.08) -2.2  (2.04) -1.8  (1.64)
Investigator Number Analyzed 17 participants 19 participants 21 participants
-1.1  (1.27) -0.7  (1.15) -0.7  (1.23)
31.Primary Outcome
Title Change From Baseline in Daily Seizure Activity
Hide Description The specific number of tonic and atonic seizures per study day were recorded in a diary. The change in number of seizures at Day 11 relative to Baseline is reported. A negative change from Baseline indicates an improvement based on Daily Seizure Activity.
Time Frame Baseline and Day 11
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Hide Analysis Population Description
EFF, all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for number of seizures per day at Day 11.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 20 20 21
Mean (Standard Deviation)
Unit of Measure: number of seizures per day
Number of Tonic Seizures Number Analyzed 19 participants 13 participants 19 participants
-0.8  (1.55) -0.8  (1.59) -2.9  (7.69)
Number of Atonic Seizures Number Analyzed 19 participants 13 participants 19 participants
-0.2  (0.98) -0.1  (0.28) 0.0  (0.00)
32.Primary Outcome
Title Number of Participants With Suicide Related Thoughts and Behaviors Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description The C-SSRS captured the occurrence, severity, and frequency of suicide related thoughts and behaviors at Day 11. The C-SSRS was only used for participants ≥ 7 years of age. The number of participants with results of “Yes” for Suicidal Ideation (Wish to be Dead and Non-Specific Active Suicidal Thoughts) and Suicidal Behavior (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior, and Suicidal Behavior) are reported.
Time Frame Day 11
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Hide Analysis Population Description
Participants from the Safety Analysis Population (SAF), all participants who received ≥1 dose of the investigational product, who completed the C-SSRS.
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description:
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Overall Number of Participants Analyzed 4 5 4
Measure Type: Count of Participants
Unit of Measure: Participants
Suicide Ideation
0
   0.0%
0
   0.0%
0
   0.0%
Suicide Behavior
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame From the first dose of study drug to 7 days after the last dose of study drug (up to Day 17)
Adverse Event Reporting Description Participants who completed all study activities for this study had the option to participate in a rollover study. Participants who enrolled into the rollover study may not have had adverse event data collected after Day 11.
 
Arm/Group Title Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Hide Arm/Group Description Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10. Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10. High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
All-Cause Mortality
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   1/20 (5.00%)   2/21 (9.52%) 
Respiratory, thoracic and mediastinal disorders       
Apnoea  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Skin and subcutaneous tissue disorders       
Drug eruption  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Vascular disorders       
Thrombophlebitis  1  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
1
Term from vocabulary, MedDRA (18.0)
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 4%
Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] High Dose Cannabidiol Oral Solution [40 mg/kg/Day]
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/20 (65.00%)   9/20 (45.00%)   17/21 (80.95%) 
Blood and lymphatic system disorders       
Anaemia  1  2/20 (10.00%)  5/20 (25.00%)  4/21 (19.05%) 
Cardiac disorders       
Nodal rhythm  1  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Tachycardia  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Ear and labyrinth disorders       
Ear pain  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Eye disorders       
Eye pain  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Gastrointestinal disorders       
Diarrhoea  1  1/20 (5.00%)  2/20 (10.00%)  7/21 (33.33%) 
Flatulence  1  0/20 (0.00%)  2/20 (10.00%)  3/21 (14.29%) 
Abdominal pain upper  1  2/20 (10.00%)  1/20 (5.00%)  0/21 (0.00%) 
Vomiting  1  2/20 (10.00%)  1/20 (5.00%)  0/21 (0.00%) 
Oral mucosal erythema  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Oral pain  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Dysphagia  1  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Constipation  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Gastrooesophageal reflux disease  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Nausea  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
General disorders       
Catheter site pruritus  1  0/20 (0.00%)  2/20 (10.00%)  1/21 (4.76%) 
Pyrexia  1  1/20 (5.00%)  0/20 (0.00%)  1/21 (4.76%) 
Fatigue  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Thirst  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Injection site reaction  1  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Catheter site pain  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Infections and infestations       
Lice infestation  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Upper respiratory tract infection  1  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
Adenovirus infection  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Clostridium difficile infection  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Escherichia urinary tract infection  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Urinary tract infection  1  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Injury, poisoning and procedural complications       
Skin abrasion  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Investigations       
Weight increased  1  0/20 (0.00%)  1/20 (5.00%)  2/21 (9.52%) 
Weight decreased  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Blood follicle stimulating hormone increased  1  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Blood follicle stimulating hormone decreased  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Urine analysis abnormal  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Alanine aminotransferase increase  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Metabolism and nutrition disorders       
Decreased appetite  1  2/20 (10.00%)  0/20 (0.00%)  1/21 (4.76%) 
Dehydration  1  0/20 (0.00%)  0/20 (0.00%)  2/21 (9.52%) 
Metabolic acidosis  1  0/20 (0.00%)  0/20 (0.00%)  2/21 (9.52%) 
Hyperphosphataemia  1  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Hypocalcaemia  1  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Hyperglycaemia  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Nervous system disorders       
Somnolence  1  3/20 (15.00%)  3/20 (15.00%)  7/21 (33.33%) 
Psychomotor hyperactivity  1  0/20 (0.00%)  2/20 (10.00%)  3/21 (14.29%) 
Seizure  1  1/20 (5.00%)  1/20 (5.00%)  1/21 (4.76%) 
Ataxia  1  0/20 (0.00%)  0/20 (0.00%)  2/21 (9.52%) 
Hypersomnia  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Syncope  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Dizziness  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Headache  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Lethargy  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Sedation  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Tremor  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Psychiatric disorders       
Insomnia  1  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
Aggression  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Agitation  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Irritability  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Renal and urinary disorders       
Proteinuria  1  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/20 (5.00%)  1/20 (5.00%)  0/21 (0.00%) 
Dyspnoea  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Rhinorrhoea  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Asthma  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Wheezing  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
Skin and subcutaneous tissue disorders       
Dermatitis contact  1  0/20 (0.00%)  2/20 (10.00%)  0/21 (0.00%) 
Ecchymosis  1  0/20 (0.00%)  1/20 (5.00%)  1/21 (4.76%) 
Dermatitis  1  1/20 (5.00%)  0/20 (0.00%)  0/21 (0.00%) 
Rash macular  1  0/20 (0.00%)  1/20 (5.00%)  0/21 (0.00%) 
Pruritus  1  0/20 (0.00%)  0/20 (0.00%)  1/21 (4.76%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Director, Clinical Development
Organization: Insys Therapeutics, Inc.
Phone: 480-500-3105
Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02324673     History of Changes
Other Study ID Numbers: INS011-14-029
First Submitted: December 12, 2014
First Posted: December 24, 2014
Results First Submitted: May 30, 2017
Results First Posted: June 23, 2017
Last Update Posted: June 23, 2017