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Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy
Sponsor: Neurelis, Inc.
Summary
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.
Official title: An Open-Label, Single-Dose, Pharmacokinetics Study of VALTOCO® With Open-Label Safety Period in Pediatric Subjects With Epilepsy
Key Details
Gender
All
Age Range
2 Years - 5 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2021-11-08
Completion Date
2025-03-11
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
Diazepam Nasal Spray [Valtoco]
5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight.
Locations (13)
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
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
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States