Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

Neurelis

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Epilepsy

Treatments

Drug: Diazepam Nasal Spray [Valtoco]

Study type

Interventional

Funder types

Industry

Identifiers

DIAZ.001.08

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.