Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

November 8, 2021

Primary Completion Date

March 11, 2025

Study Completion Date

March 11, 2025

Conditions
Epilepsy
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.

Trial Locations (13)

10532

Boston Children's Health Physicians, Hawthorne

14623

University of Rochester, Rochester

23507

Children's Hospital of the King's Daughters, Norfolk

27710

Duke University Hospital, Durham

30093

Center for Rare Neurological Diseases, Norcross

32561

Northwest Florida Clinical Research Group, LLC., Gulf Breeze

32803

AdventHealth Research Institute, Orlando

33155

Nicklaus Children's Hospital, Miami

38105

Le Bonheur Children's Hospital, Memphis

65201

University of Missouri Women & Children's Hospital, Columbia

75225

UT Southwestern Medical Center, Dallas

02114

Massachusetts General Hospital, Boston

07601

Northeast Regional Epilepsy Group, Hackensack

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Neurelis, Inc.

INDUSTRY

NCT05076838 - Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy | Biotech Hunter | Biotech Hunter