Cannabidiol Oral Solution in Pediatric Subjects With Treatment- Resistant Seizure Disorders



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:1 - 17
Updated:4/21/2016
Start Date:April 2015
End Date:April 2016
Contact:Clinical Operations
Email:insyscbd@insysrx.com

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A Phase 1/2 Study to Assess the Pharmacokinetics and Safety of Multiple Doses of Pharmaceutical Cannabidiol Oral Solution in Pediatric Subjects With Treatment- Resistant Seizure Disorders

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.


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
We found this trial at
11
sites
Pensacola, Florida 32504
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3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
Miami Children's Hospital Welcome to Miami Children
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, IL
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Dallas, TX
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Las Vegas, Nevada 89104
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Memphis, Tennessee 38103
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Portland, Oregon 97239
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Riverton, Utah 84096
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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Tacoma, Washington 98405
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Tacoma, WA
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