Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

Completed · Phase 1/Phase 2

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT05076838

Run by

Neurelis, Inc.

People needed

35

Starts

2021-11-08

Expected to finish

2025-03-11

Last updated by the study team

2025-08-11

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has a clinical diagnosis of epilepsy and, in the opinion of the Investigator, may need benzodiazepine intervention for seizure control.
• Subjects having either partial or generalized epilepsy with motor seizures or seizures with clear alteration of awareness, for which rescue medications have been used at least once in the last 3 months or in the opinion of the investigator, may need a benzodiazepine intervention for seizure control 1-2 times every 3 months on average.

You may not qualify if…

• Subjects whose body weight are < 6 kg or > 33 kg.
• Subject is undergoing intracranial electroencephalogram (EEG) monitoring.
• In the opinion of the investigator, a history of clinically significant medical history that would jeopardize the safety of the subject or impact the validity of the study results (such as significant gastrointestinal, renal, nasal polyps or any nasal passage abnormality that could interfere with nasal spray administration.
• Subject has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.
• Participation in a clinical trial within 30 days prior to the first dose of study drug.
• Inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.

Where it is running

• 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

Full record on ClinicalTrials.gov

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