Trial Outcomes & Findings for Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders (NCT NCT02324673)

Last Updated: 2017-06-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

61 participants

Primary outcome timeframe

Day 1 at age-specific times

Results posted on

2017-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] 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 Cannabidiol Oral Solution [20 mg/kg/Day] 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 Cannabidiol Oral Solution [40 mg/kg/Day] 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 Study STARTED	20	20	21
Overall Study COMPLETED	20	20	21
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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 n=61 Participants Total of all reporting groups
Age, Continuous	7.5 years STANDARD_DEVIATION 5.32 • n=5 Participants	7.7 years STANDARD_DEVIATION 5.17 • n=7 Participants	7.8 years STANDARD_DEVIATION 5.39 • n=5 Participants	7.6 years STANDARD_DEVIATION 5.21 • n=4 Participants
Age, Customized Infants = 1 to <2 years	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Age, Customized Children = 2 to <12 years	9 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	28 Participants n=4 Participants
Age, Customized Adolescents = 12 to ≤17 years	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	18 Participants n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	33 Participants n=4 Participants
Region of Enrollment United States	20 Participants n=5 Participants	20 Participants n=7 Participants	21 Participants n=5 Participants	61 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Population: 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.

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol Cannabidiol	110.5 nanograms/milliliter (ng/mL) Standard Deviation 142.3	256.9 nanograms/milliliter (ng/mL) Standard Deviation 351.9	59.03 nanograms/milliliter (ng/mL) Standard Deviation 99.98
Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol 7-OH Cannabidiol	61.89 nanograms/milliliter (ng/mL) Standard Deviation 72.88	140.9 nanograms/milliliter (ng/mL) Standard Deviation 210.0	28.71 nanograms/milliliter (ng/mL) Standard Deviation 26.72

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Cmax for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	220.0 ng/mL Standard Deviation 294.7	426.8 ng/mL Standard Deviation 327.7	119.6 ng/mL Standard Deviation 105.0
Cmax for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	136.6 ng/mL Standard Deviation 140.9	286.1 ng/mL Standard Deviation 201.9	79.38 ng/mL Standard Deviation 40.82

PRIMARY outcome

Timeframe: Day 1 at age-specific times

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.

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Dose Normalized Cmax (Cmax/D) for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	10.77 ng/mL/(mg/kg) Standard Deviation 13.97	13.25 ng/mL/(mg/kg) Standard Deviation 18.07	11.72 ng/mL/(mg/kg) Standard Deviation 19.89
Dose Normalized Cmax (Cmax/D) for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	5.990 ng/mL/(mg/kg) Standard Deviation 7.011	7.286 ng/mL/(mg/kg) Standard Deviation 10.91	5.737 ng/mL/(mg/kg) Standard Deviation 5.330

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Cmax/D for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	21.16 ng/mL/(mg/kg) Standard Deviation 28.40	21.40 ng/mL/(mg/kg) Standard Deviation 16.38	23.79 ng/mL/(mg/kg) Standard Deviation 20.46
Cmax/D for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	13.10 ng/mL/(mg/kg) Standard Deviation 13.06	14.39 ng/mL/(mg/kg) Standard Deviation 10.26	15.82 ng/mL/(mg/kg) Standard Deviation 7.928

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	4.00 hours (h) Interval 1.0 to 8.08	3.15 hours (h) Interval 1.0 to 24.02	2.58 hours (h) Interval 1.02 to 8.0
Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	4.00 hours (h) Interval 1.0 to 11.95	3.07 hours (h) Interval 1.0 to 12.05	2.55 hours (h) Interval 1.0 to 6.08

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	2.00 h Interval 0.0 to 6.0	3.00 h Interval 0.0 to 6.02	2.99 h Interval 1.0 to 4.25
Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	2.03 h Interval 1.0 to 6.05	2.03 h Interval 0.0 to 5.9	2.08 h Interval 1.0 to 4.08

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=15 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=16 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=15 Participants 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.
Half Life (t1/2) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age Cannabidiol	33.48 h Standard Deviation 14.97	21.58 h Standard Deviation 10.50	31.31 h Standard Deviation 23.46
Half Life (t1/2) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age 7-OH Cannabidiol	31.84 h Standard Deviation 24.28	14.77 h Standard Deviation 4.354	19.71 h Standard Deviation 7.640

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=15 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=16 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=15 Participants 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.
Elimination Rate (Lambda-z [λz]) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age Cannabidiol	0.02836 1/h Standard Deviation 0.02340	0.03949 1/h Standard Deviation 0.01976	0.02969 1/h Standard Deviation 0.01386
Elimination Rate (Lambda-z [λz]) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age 7-OH Cannabidiol	0.03276 1/h Standard Deviation 0.01985	0.05123 1/h Standard Deviation 0.01711	0.04053 1/h Standard Deviation 0.01557

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=8 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=12 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=10 Participants 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.
Oral Clearance (CL/F) for Cannabidiol for Participants ≥2 Years of Age	21.10 Liters (L)/h/kg Standard Deviation 23.04	31.29 Liters (L)/h/kg Standard Deviation 30.43	29.78 Liters (L)/h/kg Standard Deviation 15.96

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=8 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=12 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=10 Participants 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.
Volume of Distribution (Vz/F) of Cannabidiol for Participants ≥2 Years of Age	930.8 L/kg Standard Deviation 1034	982.6 L/kg Standard Deviation 1119	1021 L/kg Standard Deviation 609.1

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
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 Cannabidiol	507.1 ng*h/mL Standard Deviation 687.7	914.5 ng*h/mL Standard Deviation 1155	173.9 ng*h/mL Standard Deviation 179.6
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 7-OH Cannabidiol	329.8 ng*h/mL Standard Deviation 402.9	646.7 ng*h/mL Standard Deviation 886.3	124.4 ng*h/mL Standard Deviation 80.18

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 7-OH Cannabidiol	31.77 ng*h/mL Standard Deviation 38.00	33.39 ng*h/mL Standard Deviation 45.94	24.88 ng*h/mL Standard Deviation 15.93
Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 Cannabidiol	49.23 ng*h/mL Standard Deviation 66.68	47.13 ng*h/mL Standard Deviation 59.38	34.60 ng*h/mL Standard Deviation 35.48

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=15 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=16 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=15 Participants 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.
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 Cannabidiol	692.5 ng*h/mL Standard Deviation 826.9	1355 ng*h/mL Standard Deviation 1447	250.0 ng*h/mL Standard Deviation 217.1
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 7-OH Cannabidiol	544.9 ng*h/mL Standard Deviation 526.6	1221 ng*h/mL Standard Deviation 1296	212.2 ng*h/mL Standard Deviation 112.1

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=15 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=16 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=15 Participants 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.
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 Cannabidiol	1140 ng*h/mL Standard Deviation 1118	1584 ng*h/mL Standard Deviation 1709	270.1 ng*h/mL Standard Deviation 256.7
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 7-OH Cannabidiol	704.1 ng*h/mL Standard Deviation 627.8	1354 ng*h/mL Standard Deviation 1428	229.3 ng*h/mL Standard Deviation 122.3

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=15 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=16 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=15 Participants 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.
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 Cannabidiol	111.8 ng*h/mL/(mg/kg) Standard Deviation 111.2	83.10 ng*h/mL/(mg/kg) Standard Deviation 87.93	53.64 ng*h/mL/(mg/kg) Standard Deviation 50.04
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 7-OH Cannabidiol	68.43 ng*h/mL/(mg/kg) Standard Deviation 62.34	70.34 ng*h/mL/(mg/kg) Standard Deviation 73.66	46.07 ng*h/mL/(mg/kg) Standard Deviation 24.63

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Metabolite (7-OH Cannabidiol) to Parent (Cannabidiol) Ratio for Cmax [MRCmax] on Day 1	0.9328 ratio Standard Deviation 0.8332	0.8081 ratio Standard Deviation 0.4849	0.8935 ratio Standard Deviation 0.5543

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=17 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
MRCmax on Day 10	0.8230 ratio Standard Deviation 0.3880	0.7657 ratio Standard Deviation 0.4179	0.7717 ratio Standard Deviation 0.3960

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=8 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=12 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=10 Participants 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.
Metabolite to Parent Ratio for AUC(0-inf) [MRAUC(0-inf)] on Day 1 for Participants ≥2 Years of Age	0.9459 ratio Standard Deviation 0.4874	0.9538 ratio Standard Deviation 0.4370	0.9099 ratio Standard Deviation 0.5173

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=19 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 1	0.9793 ratio Standard Deviation 0.7147	0.9085 ratio Standard Deviation 0.5075	0.9309 ratio Standard Deviation 0.5229

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=17 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=19 Participants 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.
Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 10	0.7866 ratio Standard Deviation 0.2361	0.8700 ratio Standard Deviation 0.4304	0.8795 ratio Standard Deviation 0.4084

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
AUC(0-12) for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10 Cannabidiol	1098 ng*h/mL Standard Deviation 976.4	2708 ng*h/mL Standard Deviation 1789	581.6 ng*h/mL Standard Deviation 283.4
AUC(0-12) for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10 7-OH Cannabidiol	832.8 ng*h/mL Standard Deviation 675.2	2165 ng*h/mL Standard Deviation 1405	513.4 ng*h/mL Standard Deviation 269.0

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10 7-OH Cannabidiol	80.19 ng*h/mL/(mg/kg) Standard Deviation 63.53	108.7 ng*h/mL/(mg/kg) Standard Deviation 70.76	102.2 ng*h/mL/(mg/kg) Standard Deviation 53.01
Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10 Cannabidiol	106.0 ng*h/mL/(mg/kg) Standard Deviation 94.64	135.7 ng*h/mL/(mg/kg) Standard Deviation 89.17	115.8 ng*h/mL/(mg/kg) Standard Deviation 55.32

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Minimum Plasma Concentration (Cmin) for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	41.67 ng/mL Standard Deviation 25.41	118.3 ng/mL Standard Deviation 75.82	19.97 ng/mL Standard Deviation 8.798
Minimum Plasma Concentration (Cmin) for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	34.11 ng/mL Standard Deviation 23.99	108.7 ng/mL Standard Deviation 70.87	21.82 ng/mL Standard Deviation 13.23

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Average Plasma Concentration (Cavg) for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	91.38 ng/mL Standard Deviation 80.92	225.7 ng/mL Standard Deviation 149.3	48.56 ng/mL Standard Deviation 23.58
Average Plasma Concentration (Cavg) for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	69.37 ng/mL Standard Deviation 56.09	180.4 ng/mL Standard Deviation 117.1	42.94 ng/mL Standard Deviation 22.54

PRIMARY outcome

Timeframe: Day 10 at age-specific times

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.

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Accumulation Ratio for Cmax (RCmax) on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	4.454 ratio Standard Deviation 4.466	7.488 ratio Standard Deviation 11.93	5.535 ratio Standard Deviation 5.551
Accumulation Ratio for Cmax (RCmax) on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	3.996 ratio Standard Deviation 3.544	5.788 ratio Standard Deviation 6.028	3.823 ratio Standard Deviation 2.730

PRIMARY outcome

Timeframe: Day 10 at age-specific times

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.

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Accumulation Ratio for AUC(0-12) [RAUC(0-12)] on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	5.489 ratio Standard Deviation 4.633	9.376 ratio Standard Deviation 15.11	5.434 ratio Standard Deviation 3.625
Accumulation Ratio for AUC(0-12) [RAUC(0-12)] on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	4.524 ratio Standard Deviation 3.338	7.541 ratio Standard Deviation 7.187	4.865 ratio Standard Deviation 2.748

PRIMARY outcome

Timeframe: Day 1 and Day 10

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.

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=15 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=16 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=15 Participants 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.
Time Linearity Index for Cannabidiol and Metabolite 7-OH Cannabidiol in Participants ≥2 Years of Age Cannabidiol	2.628 ratio Standard Deviation 2.276	4.201 ratio Standard Deviation 4.990	3.211 ratio Standard Deviation 2.048
Time Linearity Index for Cannabidiol and Metabolite 7-OH Cannabidiol in Participants ≥2 Years of Age 7-OH Cannabidiol	1.821 ratio Standard Deviation 1.162	3.045 ratio Standard Deviation 2.260	2.500 ratio Standard Deviation 0.9365

PRIMARY outcome

Timeframe: From the first dose of study drug up to Day 17

Population: Safety Analysis Population (SAF), all participants who received ≥1 dose of the investigational product.

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.

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAE	9 Participants	17 Participants	13 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAE	1 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 11

Population: Efficacy Analysis Population (EFF), all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for CGI-I post-dose.

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.

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Clinical Global Impression of Improvement (CGI-I) Assessment Parents/Caregivers	2.4 scores on a scale Standard Deviation 0.82	2.3 scores on a scale Standard Deviation 1.15	2.1 scores on a scale Standard Deviation 1.02
Clinical Global Impression of Improvement (CGI-I) Assessment Investigator	2.5 scores on a scale Standard Deviation 0.94	2.9 scores on a scale Standard Deviation 0.91	2.7 scores on a scale Standard Deviation 0.92

PRIMARY outcome

Timeframe: Baseline and Day 11

Population: EFF, all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for CGI-S post-dose.

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).

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Assessment Parents/Caregivers	-2.2 scores on a scale Standard Deviation 2.04	-1.8 scores on a scale Standard Deviation 1.64	-1.7 scores on a scale Standard Deviation 2.08
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Assessment Investigator	-0.7 scores on a scale Standard Deviation 1.15	-0.7 scores on a scale Standard Deviation 1.23	-1.1 scores on a scale Standard Deviation 1.27

PRIMARY outcome

Timeframe: Baseline and Day 11

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=20 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 Participants 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.
Change From Baseline in Daily Seizure Activity Number of Tonic Seizures	-0.8 number of seizures per day Standard Deviation 1.59	-2.9 number of seizures per day Standard Deviation 7.69	-0.8 number of seizures per day Standard Deviation 1.55
Change From Baseline in Daily Seizure Activity Number of Atonic Seizures	-0.1 number of seizures per day Standard Deviation 0.28	0.0 number of seizures per day Standard Deviation 0.00	-0.2 number of seizures per day Standard Deviation 0.98

PRIMARY outcome

Timeframe: Day 11

Population: Participants from the Safety Analysis Population (SAF), all participants who received ≥1 dose of the investigational product, who completed the C-SSRS.

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.

Outcome measures

Outcome measures
Measure	Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day] n=5 Participants 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=4 Participants 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.	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=4 Participants 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.
Number of Participants With Suicide Related Thoughts and Behaviors Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicide Ideation	0 Participants	0 Participants	0 Participants
Number of Participants With Suicide Related Thoughts and Behaviors Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicide Behavior	0 Participants	0 Participants	0 Participants

Adverse Events

Low Dose Cannabidiol Oral Solution [10 mg/kg/Day]

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Mid Dose Cannabidiol Oral Solution [20 mg/kg/Day]

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

High Dose Cannabidiol Oral Solution [40 mg/kg/Day]

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Low Dose Cannabidiol Oral Solution [10 mg/kg/Day] n=20 participants at risk 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 Cannabidiol Oral Solution [20 mg/kg/Day] n=20 participants at risk 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 Cannabidiol Oral Solution [40 mg/kg/Day] n=21 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/20 • From the first dose of study drug to 7 days after the last dose of study drug (up to Day 17) 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.	0.00% 0/20 • From the first dose of study drug to 7 days after the last dose of study drug (up to Day 17) 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.	4.8% 1/21 • From the first dose of study drug to 7 days after the last dose of study drug (up to Day 17) 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.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/20 • From the first dose of study drug to 7 days after the last dose of study drug (up to Day 17) 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.	0.00% 0/20 • From the first dose of study drug to 7 days after the last dose of study drug (up to Day 17) 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.	4.8% 1/21 • From the first dose of study drug to 7 days after the last dose of study drug (up to Day 17) 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.
Vascular disorders Thrombophlebitis	0.00% 0/20 • From the first dose of study drug to 7 days after the last dose of study drug (up to Day 17) 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.	5.0% 1/20 • From the first dose of study drug to 7 days after the last dose of study drug (up to Day 17) 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.	0.00% 0/21 • From the first dose of study drug to 7 days after the last dose of study drug (up to Day 17) 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.

Other adverse events

Additional Information

Director, Clinical Development

Insys Therapeutics, Inc.

Phone: 480-500-3105

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place