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=99 Participants	7.7 years STANDARD_DEVIATION 5.17 • n=107 Participants	7.8 years STANDARD_DEVIATION 5.39 • n=206 Participants	7.6 years STANDARD_DEVIATION 5.21 • n=7 Participants
Age, Customized Infants = 1 to <2 years	5 Participants n=99 Participants	5 Participants n=107 Participants	5 Participants n=206 Participants	15 Participants n=7 Participants
Age, Customized Children = 2 to <12 years	9 Participants n=99 Participants	9 Participants n=107 Participants	10 Participants n=206 Participants	28 Participants n=7 Participants
Age, Customized Adolescents = 12 to ≤17 years	6 Participants n=99 Participants	6 Participants n=107 Participants	6 Participants n=206 Participants	18 Participants n=7 Participants
Sex: Female, Male Female	10 Participants n=99 Participants	7 Participants n=107 Participants	11 Participants n=206 Participants	28 Participants n=7 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	13 Participants n=107 Participants	10 Participants n=206 Participants	33 Participants n=7 Participants
Region of Enrollment United States	20 Participants n=99 Participants	20 Participants n=107 Participants	21 Participants n=206 Participants	61 Participants n=7 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	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.
Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol Cannabidiol	59.03 nanograms/milliliter (ng/mL) Standard Deviation 99.98	110.5 nanograms/milliliter (ng/mL) Standard Deviation 142.3	256.9 nanograms/milliliter (ng/mL) Standard Deviation 351.9
Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol 7-OH Cannabidiol	28.71 nanograms/milliliter (ng/mL) Standard Deviation 26.72	61.89 nanograms/milliliter (ng/mL) Standard Deviation 72.88	140.9 nanograms/milliliter (ng/mL) Standard Deviation 210.0

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	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.
Cmax for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	119.6 ng/mL Standard Deviation 105.0	220.0 ng/mL Standard Deviation 294.7	426.8 ng/mL Standard Deviation 327.7
Cmax for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	79.38 ng/mL Standard Deviation 40.82	136.6 ng/mL Standard Deviation 140.9	286.1 ng/mL Standard Deviation 201.9

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	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.
Dose Normalized Cmax (Cmax/D) for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	11.72 ng/mL/(mg/kg) Standard Deviation 19.89	10.77 ng/mL/(mg/kg) Standard Deviation 13.97	13.25 ng/mL/(mg/kg) Standard Deviation 18.07
Dose Normalized Cmax (Cmax/D) for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	5.737 ng/mL/(mg/kg) Standard Deviation 5.330	5.990 ng/mL/(mg/kg) Standard Deviation 7.011	7.286 ng/mL/(mg/kg) Standard Deviation 10.91

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
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.
Cmax/D for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	23.79 ng/mL/(mg/kg) Standard Deviation 20.46	21.16 ng/mL/(mg/kg) Standard Deviation 28.40	21.40 ng/mL/(mg/kg) Standard Deviation 16.38
Cmax/D for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	15.82 ng/mL/(mg/kg) Standard Deviation 7.928	13.10 ng/mL/(mg/kg) Standard Deviation 13.06	14.39 ng/mL/(mg/kg) Standard Deviation 10.26

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
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.
Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	2.58 hours (h) Interval 1.02 to 8.0	4.00 hours (h) Interval 1.0 to 8.08	3.15 hours (h) Interval 1.0 to 24.02
Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	2.55 hours (h) Interval 1.0 to 6.08	4.00 hours (h) Interval 1.0 to 11.95	3.07 hours (h) Interval 1.0 to 12.05

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
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.
Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	2.99 h Interval 1.0 to 4.25	2.00 h Interval 0.0 to 6.0	3.00 h Interval 0.0 to 6.02
Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	2.08 h Interval 1.0 to 4.08	2.03 h Interval 1.0 to 6.05	2.03 h Interval 0.0 to 5.9

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	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.	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.
Half Life (t1/2) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age Cannabidiol	31.31 h Standard Deviation 23.46	33.48 h Standard Deviation 14.97	21.58 h Standard Deviation 10.50
Half Life (t1/2) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age 7-OH Cannabidiol	19.71 h Standard Deviation 7.640	31.84 h Standard Deviation 24.28	14.77 h Standard Deviation 4.354

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	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.	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.
Elimination Rate (Lambda-z [λz]) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age Cannabidiol	0.02969 1/h Standard Deviation 0.01386	0.02836 1/h Standard Deviation 0.02340	0.03949 1/h Standard Deviation 0.01976
Elimination Rate (Lambda-z [λz]) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age 7-OH Cannabidiol	0.04053 1/h Standard Deviation 0.01557	0.03276 1/h Standard Deviation 0.01985	0.05123 1/h Standard Deviation 0.01711

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	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.	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.
Oral Clearance (CL/F) for Cannabidiol for Participants ≥2 Years of Age	29.78 Liters (L)/h/kg Standard Deviation 15.96	21.10 Liters (L)/h/kg Standard Deviation 23.04	31.29 Liters (L)/h/kg Standard Deviation 30.43

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	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.	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.
Volume of Distribution (Vz/F) of Cannabidiol for Participants ≥2 Years of Age	1021 L/kg Standard Deviation 609.1	930.8 L/kg Standard Deviation 1034	982.6 L/kg Standard Deviation 1119

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
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.
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	173.9 ng*h/mL Standard Deviation 179.6	507.1 ng*h/mL Standard Deviation 687.7	914.5 ng*h/mL Standard Deviation 1155
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	124.4 ng*h/mL Standard Deviation 80.18	329.8 ng*h/mL Standard Deviation 402.9	646.7 ng*h/mL Standard Deviation 886.3

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
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.
Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 7-OH Cannabidiol	24.88 ng*h/mL Standard Deviation 15.93	31.77 ng*h/mL Standard Deviation 38.00	33.39 ng*h/mL Standard Deviation 45.94
Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 Cannabidiol	34.60 ng*h/mL Standard Deviation 35.48	49.23 ng*h/mL Standard Deviation 66.68	47.13 ng*h/mL Standard Deviation 59.38

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	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.	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.
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	250.0 ng*h/mL Standard Deviation 217.1	692.5 ng*h/mL Standard Deviation 826.9	1355 ng*h/mL Standard Deviation 1447
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	212.2 ng*h/mL Standard Deviation 112.1	544.9 ng*h/mL Standard Deviation 526.6	1221 ng*h/mL Standard Deviation 1296

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	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.	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.
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	270.1 ng*h/mL Standard Deviation 256.7	1140 ng*h/mL Standard Deviation 1118	1584 ng*h/mL Standard Deviation 1709
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	229.3 ng*h/mL Standard Deviation 122.3	704.1 ng*h/mL Standard Deviation 627.8	1354 ng*h/mL Standard Deviation 1428

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	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.	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.
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	53.64 ng*h/mL/(mg/kg) Standard Deviation 50.04	111.8 ng*h/mL/(mg/kg) Standard Deviation 111.2	83.10 ng*h/mL/(mg/kg) Standard Deviation 87.93
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	46.07 ng*h/mL/(mg/kg) Standard Deviation 24.63	68.43 ng*h/mL/(mg/kg) Standard Deviation 62.34	70.34 ng*h/mL/(mg/kg) Standard Deviation 73.66

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
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.
Metabolite (7-OH Cannabidiol) to Parent (Cannabidiol) Ratio for Cmax [MRCmax] on Day 1	0.8935 ratio Standard Deviation 0.5543	0.9328 ratio Standard Deviation 0.8332	0.8081 ratio Standard Deviation 0.4849

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
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=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.
MRCmax on Day 10	0.7717 ratio Standard Deviation 0.3960	0.8230 ratio Standard Deviation 0.3880	0.7657 ratio Standard Deviation 0.4179

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
Measure	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.	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.
Metabolite to Parent Ratio for AUC(0-inf) [MRAUC(0-inf)] on Day 1 for Participants ≥2 Years of Age	0.9099 ratio Standard Deviation 0.5173	0.9459 ratio Standard Deviation 0.4874	0.9538 ratio Standard Deviation 0.4370

PRIMARY outcome

Timeframe: Day 1 at age-specific times

Outcome measures

Outcome measures
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=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.
Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 1	0.9309 ratio Standard Deviation 0.5229	0.9793 ratio Standard Deviation 0.7147	0.9085 ratio Standard Deviation 0.5075

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
Measure	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.	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.
Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 10	0.8795 ratio Standard Deviation 0.4084	0.7866 ratio Standard Deviation 0.2361	0.8700 ratio Standard Deviation 0.4304

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
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.
AUC(0-12) for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10 Cannabidiol	581.6 ng*h/mL Standard Deviation 283.4	1098 ng*h/mL Standard Deviation 976.4	2708 ng*h/mL Standard Deviation 1789
AUC(0-12) for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10 7-OH Cannabidiol	513.4 ng*h/mL Standard Deviation 269.0	832.8 ng*h/mL Standard Deviation 675.2	2165 ng*h/mL Standard Deviation 1405

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

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

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
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.
Minimum Plasma Concentration (Cmin) for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	19.97 ng/mL Standard Deviation 8.798	41.67 ng/mL Standard Deviation 25.41	118.3 ng/mL Standard Deviation 75.82
Minimum Plasma Concentration (Cmin) for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	21.82 ng/mL Standard Deviation 13.23	34.11 ng/mL Standard Deviation 23.99	108.7 ng/mL Standard Deviation 70.87

PRIMARY outcome

Timeframe: Day 10 at age-specific times

Outcome measures

Outcome measures
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.
Average Plasma Concentration (Cavg) for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	48.56 ng/mL Standard Deviation 23.58	91.38 ng/mL Standard Deviation 80.92	225.7 ng/mL Standard Deviation 149.3
Average Plasma Concentration (Cavg) for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	42.94 ng/mL Standard Deviation 22.54	69.37 ng/mL Standard Deviation 56.09	180.4 ng/mL Standard Deviation 117.1

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	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.
Accumulation Ratio for Cmax (RCmax) on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	5.535 ratio Standard Deviation 5.551	4.454 ratio Standard Deviation 4.466	7.488 ratio Standard Deviation 11.93
Accumulation Ratio for Cmax (RCmax) on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	3.823 ratio Standard Deviation 2.730	3.996 ratio Standard Deviation 3.544	5.788 ratio Standard Deviation 6.028

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	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.
Accumulation Ratio for AUC(0-12) [RAUC(0-12)] on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol Cannabidiol	5.434 ratio Standard Deviation 3.625	5.489 ratio Standard Deviation 4.633	9.376 ratio Standard Deviation 15.11
Accumulation Ratio for AUC(0-12) [RAUC(0-12)] on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol 7-OH Cannabidiol	4.865 ratio Standard Deviation 2.748	4.524 ratio Standard Deviation 3.338	7.541 ratio Standard Deviation 7.187

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	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.	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.
Time Linearity Index for Cannabidiol and Metabolite 7-OH Cannabidiol in Participants ≥2 Years of Age 7-OH Cannabidiol	2.500 ratio Standard Deviation 0.9365	1.821 ratio Standard Deviation 1.162	3.045 ratio Standard Deviation 2.260
Time Linearity Index for Cannabidiol and Metabolite 7-OH Cannabidiol in Participants ≥2 Years of Age Cannabidiol	3.211 ratio Standard Deviation 2.048	2.628 ratio Standard Deviation 2.276	4.201 ratio Standard Deviation 4.990

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	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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAE	13 Participants	9 Participants	17 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAE	0 Participants	1 Participants	2 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	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.
Clinical Global Impression of Improvement (CGI-I) Assessment Parents/Caregivers	2.1 scores on a scale Standard Deviation 1.02	2.4 scores on a scale Standard Deviation 0.82	2.3 scores on a scale Standard Deviation 1.15
Clinical Global Impression of Improvement (CGI-I) Assessment Investigator	2.7 scores on a scale Standard Deviation 0.92	2.5 scores on a scale Standard Deviation 0.94	2.9 scores on a scale Standard Deviation 0.91

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	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.
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Assessment Investigator	-1.1 scores on a scale Standard Deviation 1.27	-0.7 scores on a scale Standard Deviation 1.15	-0.7 scores on a scale Standard Deviation 1.23
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Assessment Parents/Caregivers	-1.7 scores on a scale Standard Deviation 2.08	-2.2 scores on a scale Standard Deviation 2.04	-1.8 scores on a scale Standard Deviation 1.64

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	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.
Change From Baseline in Daily Seizure Activity Number of Tonic Seizures	-0.8 number of seizures per day Standard Deviation 1.55	-0.8 number of seizures per day Standard Deviation 1.59	-2.9 number of seizures per day Standard Deviation 7.69
Change From Baseline in Daily Seizure Activity Number of Atonic Seizures	-0.2 number of seizures per day Standard Deviation 0.98	-0.1 number of seizures per day Standard Deviation 0.28	0.0 number of seizures per day Standard Deviation 0.00

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	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.	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.
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