The primary purpose of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in pediatric participants with treatment-resistant childhood absence seizures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Nicklaus Children's Hospital
Miami, Florida, United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, United States
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. An 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. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported AEs module.
Time frame: Baseline (Visit 6 of INS011-17-103) and Visit 10 (up to approximately 54 weeks)
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Akron Children's Hospital
Akron, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Children's Specialty Group, Division of Child & Adolescent Neurology
Norfolk, Virginia, United States
Institute for Research and Innovation | MultiCare Health System
Tacoma, Washington, United States