Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT05076838
PHASE1/PHASE2

Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

Sponsor: Neurelis, Inc.

View on ClinicalTrials.gov

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

DRUG

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