Back to resultsCannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders
Primary Purpose
Seizures
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol Oral Solution
Sponsored by
About this trial
This is an interventional treatment trial for Seizures focused on measuring Treatment-resistant seizures
Eligibility Criteria
Inclusion Criteria:
- Meets protocol-specified criteria for qualification and contraception, including treatment-resistant seizure disorder
- Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
- In the opinion of the Investigator, the participants and parent(s)/caregiver(s) are willing and able to comply with the study procedures and visit schedules, including venipuncture, inpatient stay at the study center, dosing at the study center twice a day as needed while an outpatient), and the Follow-up Visits (if applicable)
Exclusion Criteria:
- Participant or parent(s)/caregiver(s) have daily commitments during the study duration that would interfere with attending all study visits
- History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters
Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
- the safety or well-being of the participant or study staff
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
- the analysis of results
Sites / Locations
- University of California San Francisco Medical Center
- Miami Children's Hospital
- Child Neurology Center - NW F
- University of Chicago Medical Center
- Clinical Research Center of Nevada LLC
- Oregon Health Services University
- Children's Hospital of Philadelphia
- Le Bonheur Children's Hospital
- Texas Scottish Rite Hospital for Children
- Mary Bridge Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Low Dose Cannabidiol Oral Solution [10 mg/kg/day]
Mid Dose Cannabidiol Oral Solution [20 mg/kg/day]
High Dose Cannabidiol Oral Solution [40 mg/kg/day]
Arm Description
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Mid Dose [20 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10.
High Dose [40 mg/kg/day] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Outcomes
Primary Outcome Measures
Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol
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.
Cmax for Cannabidiol and Metabolite 7-OH Cannabidiol
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.
Dose Normalized Cmax (Cmax/D) for Cannabidiol and Metabolite 7-OH Cannabidiol
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.
Cmax/D for Cannabidiol and Metabolite 7-OH Cannabidiol
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol
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.
Half Life (t1/2) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age
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.
Elimination Rate (Lambda-z [λz]) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age
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.
Oral Clearance (CL/F) for Cannabidiol for Participants ≥2 Years of Age
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.
Volume of Distribution (Vz/F) of Cannabidiol for Participants ≥2 Years of Age
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.
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
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on 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 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
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
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.
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
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.
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
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.
Metabolite (7-OH Cannabidiol) to Parent (Cannabidiol) Ratio for Cmax [MRCmax] on 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 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
MRCmax on Day 10
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Metabolite to Parent Ratio for AUC(0-inf) [MRAUC(0-inf)] on Day 1 for Participants ≥2 Years of Age
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.
MRAUC(0-inf) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on 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 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 10
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
AUC(0-12) for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10
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.
Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10
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.
Minimum Plasma Concentration (Cmin) for Cannabidiol and Metabolite 7-OH Cannabidiol
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.
Average Plasma Concentration (Cavg) for Cannabidiol and Metabolite 7-OH Cannabidiol
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.
Accumulation Ratio for Cmax (RCmax) on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol
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.
Accumulation Ratio for AUC(0-12) [RAUC(0-12)] on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol
RAUC(0-12) is the ratio of AUC(0-12) at Day 10 compared to AUC(0-12) at Day 1.
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time Linearity Index for Cannabidiol and Metabolite 7-OH Cannabidiol in Participants ≥2 Years of Age
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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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.
Clinical Global Impression of Improvement (CGI-I) Assessment
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.
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Assessment
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).
Change From Baseline in Daily Seizure Activity
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.
Number of Participants With Suicide Related Thoughts and Behaviors Assessed by the Columbia-Suicide Severity Rating Scale (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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02324673
Brief Title
Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders
Official Title
A Phase 1/2 Study to Assess the Pharmacokinetics and Safety of Multiple Doses of Pharmaceutical Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Seizure Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 13, 2015 (Actual)
Primary Completion Date
May 9, 2016 (Actual)
Study Completion Date
May 9, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
INSYS Therapeutics Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral Solution in a sequential fashion.
Participants will be pediatric (aged 1-17, inclusive), experiencing treatment-resistant seizures, and satisfy all inclusion/exclusion criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizures
Keywords
Treatment-resistant seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Dose Cannabidiol Oral Solution [10 mg/kg/day]
Arm Type
Experimental
Arm Description
Low Dose [10 milligrams/kilogram/day (mg/kg/day)] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10.
Arm Title
Mid Dose Cannabidiol Oral Solution [20 mg/kg/day]
Arm Type
Experimental
Arm Description
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.
Arm Title
High Dose Cannabidiol Oral Solution [40 mg/kg/day]
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cannabidiol Oral Solution
Intervention Description
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Time Frame
Day 1 at age-specific times
Title
Cmax for Cannabidiol and Metabolite 7-OH Cannabidiol
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time Frame
Day 10 at age-specific times
Title
Dose Normalized Cmax (Cmax/D) for Cannabidiol and Metabolite 7-OH Cannabidiol
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Time Frame
Day 1 at age-specific times
Title
Cmax/D for Cannabidiol and Metabolite 7-OH Cannabidiol
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time Frame
Day 10 at age-specific times
Title
Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Time Frame
Day 1 at age-specific times
Title
Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time Frame
Day 10 at age-specific times
Title
Half Life (t1/2) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.
Time Frame
Day 1 at age-specific times
Title
Elimination Rate (Lambda-z [λz]) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.
Time Frame
Day 1 at age-specific times
Title
Oral Clearance (CL/F) for Cannabidiol for Participants ≥2 Years of Age
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.
Time Frame
Day 1 at age-specific times
Title
Volume of Distribution (Vz/F) of Cannabidiol for Participants ≥2 Years of Age
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.
Time Frame
Day 1 at age-specific times
Title
Area Under the Plasma-Concentration Time Curve From 0 to 12 Hours Post-dose [AUC(0-12)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Time Frame
Day 1 at age-specific times
Title
Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
Time Frame
Day 1 at age-specific times
Title
AUC From Time 0 to the Last Quantifiable Concentration [AUC(0-last)] on Day 1 for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.
Time Frame
Day 1 at age-specific times
Title
AUC From Time 0 to Infinity [AUC(0-inf)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.
Time Frame
Day 1 at age-specific times
Title
Dose Normalized AUC(0-inf) [AUC(0-inf)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.
Time Frame
Day 1 at age-specific times
Title
Metabolite (7-OH Cannabidiol) to Parent (Cannabidiol) Ratio for Cmax [MRCmax] on Day 1
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Time Frame
Day 1 at age-specific times
Title
MRCmax on Day 10
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Time Frame
Day 10 at age-specific times
Title
Metabolite to Parent Ratio for AUC(0-inf) [MRAUC(0-inf)] on Day 1 for Participants ≥2 Years of Age
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.
MRAUC(0-inf) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Time Frame
Day 1 at age-specific times
Title
Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 1
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.
MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Time Frame
Day 1 at age-specific times
Title
Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 10
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46).
Time Frame
Day 10 at age-specific times
Title
AUC(0-12) for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time Frame
Day 10 at age-specific times
Title
Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time Frame
Day 10 at age-specific times
Title
Minimum Plasma Concentration (Cmin) for Cannabidiol and Metabolite 7-OH Cannabidiol
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time Frame
Day 10 at age-specific times
Title
Average Plasma Concentration (Cavg) for Cannabidiol and Metabolite 7-OH Cannabidiol
Description
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time Frame
Day 10 at age-specific times
Title
Accumulation Ratio for Cmax (RCmax) on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol
Description
RCmax is the ratio of Cmax at Day 10 compared to Cmax at Day 1.
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time Frame
Day 10 at age-specific times
Title
Accumulation Ratio for AUC(0-12) [RAUC(0-12)] on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol
Description
RAUC(0-12) is the ratio of AUC(0-12) at Day 10 compared to AUC(0-12) at Day 1.
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.
Time Frame
Day 10 at age-specific times
Title
Time Linearity Index for Cannabidiol and Metabolite 7-OH Cannabidiol in Participants ≥2 Years of Age
Description
Time linearity index is calculated as the ratio of AUC(0-12) on Day 10/AUC[0-inf] on Day 1.
Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:
Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.
Time Frame
Day 1 and Day 10
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event not present prior to the initiation of the treatment or any event already present that worsens. Any laboratory (clinical chemistry, hematology, urinalysis), 12-lead electrocardiograms, vital signs (temperature, blood pressure, pulse rate, respiratory rate) and physical examination findings deemed by the investigator to be clinically significant were captured as AEs. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires the participant be at a risk of death at the time of the event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or other serious event that requires medical or surgical intervention.
Time Frame
From the first dose of study drug up to Day 17
Title
Clinical Global Impression of Improvement (CGI-I) Assessment
Description
The CGI-I was completed by the parents/caregivers and the investigator and was used to assess participants global status of their condition on Day 11 using a 7-point scale, where 1=very much improved and 7=very much worse since the initiation of treatment.
Time Frame
Day 11
Title
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Assessment
Description
The CGI-S was completed by the parents/caregivers and the Investigator and was used to rate participant's mental illness status at Baseline (Screening) and Day 11 using a 7-point scale, where 1=normal, not mentally ill, and 7=among the most extremely mentally ill participants. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. The change in CGI-S score at Day 11 relative to Baseline is reported. A negative change from Baseline indicates improvement (decreased severity in illness).
Time Frame
Baseline and Day 11
Title
Change From Baseline in Daily Seizure Activity
Description
The specific number of tonic and atonic seizures per study day were recorded in a diary. The change in number of seizures at Day 11 relative to Baseline is reported. A negative change from Baseline indicates an improvement based on Daily Seizure Activity.
Time Frame
Baseline and Day 11
Title
Number of Participants With Suicide Related Thoughts and Behaviors Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS captured the occurrence, severity, and frequency of suicide related thoughts and behaviors at Day 11. The C-SSRS was only used for participants ≥ 7 years of age. The number of participants with results of "Yes" for Suicidal Ideation (Wish to be Dead and Non-Specific Active Suicidal Thoughts) and Suicidal Behavior (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior, and Suicidal Behavior) are reported.
Time Frame
Day 11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meets protocol-specified criteria for qualification and contraception, including treatment-resistant seizure disorder
Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
In the opinion of the Investigator, the participants and parent(s)/caregiver(s) are willing and able to comply with the study procedures and visit schedules, including venipuncture, inpatient stay at the study center, dosing at the study center twice a day as needed while an outpatient), and the Follow-up Visits (if applicable)
Exclusion Criteria:
Participant or parent(s)/caregiver(s) have daily commitments during the study duration that would interfere with attending all study visits
History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters
Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
the safety or well-being of the participant or study staff
the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
the analysis of results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Parikh
Organizational Affiliation
INSYS Therapeutics Inc
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Child Neurology Center - NW F
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Clinical Research Center of Nevada LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Oregon Health Services University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Texas Scottish Rite Hospital for Children
City
Dallas
State/Province
Texas
ZIP/Postal Code
79219
Country
United States
Facility Name
Mary Bridge Children's Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98403
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31049885
Citation
Wheless JW, Dlugos D, Miller I, Oh DA, Parikh N, Phillips S, Renfroe JB, Roberts CM, Saeed I, Sparagana SP, Yu J, Cilio MR; INS011-14-029 Study Investigators. Pharmacokinetics and Tolerability of Multiple Doses of Pharmaceutical-Grade Synthetic Cannabidiol in Pediatric Patients with Treatment-Resistant Epilepsy. CNS Drugs. 2019 Jun;33(6):593-604. doi: 10.1007/s40263-019-00624-4.
Results Reference
derived
Learn more about this trial
Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders
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