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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02324673
Other study ID # INS011-14-029
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received December 12, 2014
Last updated May 16, 2016
Start date April 2015
Est. completion date May 2016

Study information

Verified date May 2016
Source INSYS Therapeutics Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 17 Years
Eligibility 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:

- Subject 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).

Locations

Country Name City State
United States University of Chicago Medical Center Chicago Illinois
United States Texas Scottish Rite Hospital for Children Dallas Texas
United States Clinical Research Center of Nevada LLC Las Vegas Nevada
United States Le Bonheur Children's Hospital Memphis Tennessee
United States Miami Children's Hospital Miami Florida
United States Child Neurology Center - NW F Pensacola Florida
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Oregon Health Services University Portland Oregon
United States University of California San Francisco Medical Center San Francisco California
United States Mary Bridge Children's Hospital Tacoma Washington

Sponsors (1)

Lead Sponsor Collaborator
INSYS Therapeutics Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum plasma concentration (Cmax) Categories: Cmax and dose normalized Cmax (Cmax/D) within 11 days No
Primary Time to Cmax (tmax) within 11 days No
Primary Half life (t1/2) within 11 days No
Primary Elimination rate within 11 days No
Primary Oral clearance of cannabidiol within 11 days No
Primary Volume of distribution of cannabidiol within 11 days No
Primary Area under the plasma-concentration time curve (AUC) on Day 1 Categories: AUC(0-12), AUC(0-12)/D, AUC(0-last), AUC(0-inf), AUC(0-inf)/D for participants at least 2 years old Day 1 No
Primary Metabolite to parent ratio for Cmax on Day 1 Day 1 No
Primary Metabolite to parent ratios for AUC on Day 1 Categories: AUC(0-inf), AUC(0-12) Day 1 No
Primary AUC on Day 10 Categories: AUC(0-12), AUC(0-12)/D Day 10 No
Primary Minimum plasma concentration (Cmin) on Day 10 Day 10 No
Primary Average plasma concentration (Cavg) on Day 10 Day 10 No
Primary Accumulation ratio for Cmax on Day 10 Day 10 No
Primary Accumulation ratio for AUC(0-12) on Day 10 Day 10 No
Primary Number of participants with treatment emergent adverse events within 17 days No
Primary Number of participants with clinically significant changes in physical examination and/or laboratory measurements within 11 days No
Primary Metabolite to parent ratio for Cmax on Day 10 Day 10 No
Primary Metabolite to parent ratios for AUC on Day 10 Categories: AUC(0-inf), AUC(0-12) Day 10 No
Primary Clinical Global Impression of lmprovement (CGI-I) assessment Categories: Assessed by parent(s)/caregiver(s), Assessed by investigator - The participant's overall clinical condition is compared to the one week period just before the start of medication (the baseline visit). The participant's condition is compared to the patient's condition at admission to the project [prior to starting treatment] on a 7-point scale, where 1=very much improved since the initiation of treatment; and 7=very much worse since the initiation of treatment. on Day 11 No
Primary Change from baseline in Clinical Global Impression of Severity (CGI-S) assessment Categories: Assessed by parent(s)/caregiver(s), Assessed by investigator - The severity of the participant's illness is rated on a seven-point scale, where 1=normal, not at all ill, and 7=among the most extremely ill patients. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. The score reflects the average severity level across the seven days. Baseline, Day 11 No
Primary Time linearity A linear regression analysis will assess time linearity of the individual ratios AUC(0-12) on Day 10/AUC[0-inf] on Day 1. Day 1 No
Primary Change from baseline in daily seizure activity Number of seizures per day is recorded in a diary, and the change in that number between baseline and Day 11 is calculated. Baseline, Day 11 No
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