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

Completed · Phase 1/Phase 2

Conditions studied: Seizures

In brief

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.

Key facts

Study ID

NCT02324673

Run by

INSYS Therapeutics Inc

People needed

61

Starts

2015-04-13

Expected to finish

2016-05-09

Last updated by the study team

2017-06-23

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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