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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02324673
Recruitment Status : Completed
First Posted : December 24, 2014
Results First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Study Description
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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.


Condition or disease Intervention/treatment Phase
Seizures Drug: Cannabidiol Oral Solution Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 13, 2015
Actual Primary Completion Date : May 9, 2016
Actual Study Completion Date : May 9, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Cannabidiol

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Experimental: 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.
 Drug: Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Experimental: 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.
 Drug: Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol [ Time Frame: 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 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.


  2. Cmax for Cannabidiol and Metabolite 7-OH Cannabidiol [ Time Frame: Day 10 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 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.


  3. Dose Normalized Cmax (Cmax/D) for Cannabidiol and Metabolite 7-OH Cannabidiol [ Time Frame: 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.


  4. Cmax/D for Cannabidiol and Metabolite 7-OH Cannabidiol [ Time Frame: Day 10 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 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.


  5. Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol [ Time Frame: 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 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.


  6. Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol [ Time Frame: Day 10 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 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.


  7. Half Life (t1/2) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age [ Time Frame: 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 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.


  8. Elimination Rate (Lambda-z [λz]) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age [ Time Frame: 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 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.


  9. Oral Clearance (CL/F) for Cannabidiol for Participants ≥2 Years of Age [ Time Frame: 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 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.


  10. Volume of Distribution (Vz/F) of Cannabidiol for Participants ≥2 Years of Age [ Time Frame: 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 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.


  11. 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 [ Time Frame: 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 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.


  12. Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 [ Time Frame: 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 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.


  13. 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 [ Time Frame: 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 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.


  14. 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 [ Time Frame: 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 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.


  15. 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 [ Time Frame: 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 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.


  16. Metabolite (7-OH Cannabidiol) to Parent (Cannabidiol) Ratio for Cmax [MRCmax] on Day 1 [ Time Frame: 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 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).


  17. MRCmax on Day 10 [ Time Frame: Day 10 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 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).


  18. Metabolite to Parent Ratio for AUC(0-inf) [MRAUC(0-inf)] on Day 1 for Participants ≥2 Years of Age [ Time Frame: 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 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).


  19. Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 1 [ Time Frame: 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 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).


  20. Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 10 [ Time Frame: Day 10 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 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).


  21. AUC(0-12) for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10 [ Time Frame: Day 10 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 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.


  22. Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10 [ Time Frame: Day 10 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 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.


  23. Minimum Plasma Concentration (Cmin) for Cannabidiol and Metabolite 7-OH Cannabidiol [ Time Frame: Day 10 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 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.


  24. Average Plasma Concentration (Cavg) for Cannabidiol and Metabolite 7-OH Cannabidiol [ Time Frame: Day 10 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 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.


  25. Accumulation Ratio for Cmax (RCmax) on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol [ Time Frame: 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.


  26. Accumulation Ratio for AUC(0-12) [RAUC(0-12)] on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol [ Time Frame: 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.


  27. Time Linearity Index for Cannabidiol and Metabolite 7-OH Cannabidiol in Participants ≥2 Years of Age [ Time Frame: 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.


  28. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From the first dose of study drug up to Day 17 ]
    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.

  29. Clinical Global Impression of Improvement (CGI-I) Assessment [ Time Frame: Day 11 ]
    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.

  30. Change From Baseline in Clinical Global Impression of Severity (CGI-S) Assessment [ Time Frame: Baseline and Day 11 ]
    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).

  31. Change From Baseline in Daily Seizure Activity [ Time Frame: Baseline and 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.

  32. Number of Participants With Suicide Related Thoughts and Behaviors Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Day 11 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    1. the safety or well-being of the participant or study staff
    2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
    3. the analysis of results
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324673


Locations
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United States, California
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
United States, Florida
Miami Children's Hospital
Miami, Florida, United States, 33155
Child Neurology Center - NW F
Pensacola, Florida, United States, 32504
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Nevada
Clinical Research Center of Nevada LLC
Las Vegas, Nevada, United States, 89104
United States, Oregon
Oregon Health Services University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Le Bonheur Children's Hospital
Memphis, Tennessee, United States, 38103
United States, Texas
Texas Scottish Rite Hospital for Children
Dallas, Texas, United States, 79219
United States, Washington
Mary Bridge Children's Hospital
Tacoma, Washington, United States, 98403
Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
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Study Director: Neha Parikh INSYS Therapeutics Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02324673    
Other Study ID Numbers: INS011-14-029
First Posted: December 24, 2014    Key Record Dates
Results First Posted: June 23, 2017
Last Update Posted: June 23, 2017
Last Verified: May 2017
Keywords provided by INSYS Therapeutics Inc:
Treatment-resistant seizures
Additional relevant MeSH terms:
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Seizures
Epilepsy
Neurologic Manifestations
Nervous System Diseases
 Brain Diseases
Central Nervous System Diseases
Cannabidiol
Anticonvulsants