This is a Phase 1/2a, open-label, single-dose, PK study of VALTOCO with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight.
Northwest Florida Clinical Research Group, LLC.
Gulf Breeze, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
AdventHealth Research Institute
Orlando, Florida, United States
Maximum Plasma Concentration (Cmax) of diazepam after intranasal VALTOCO administered to subjects with epilepsy 2 to 5 years of age
Time frame: 0-6 hours
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Center for Rare Neurological Diseases
Norcross, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Missouri Women & Children's Hospital
Columbia, Missouri, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
Boston Children's Health Physicians
Hawthorne, New York, United States
University of Rochester
Rochester, New York, United States
Duke University Hospital
Durham, North Carolina, United States
...and 3 more locations