Epilepsy
Conditions
Brief 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.
Interventions
DRUGDiazepam Nasal Spray [Valtoco]
5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight.
Sponsors
Neurelis, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Plasma Concentration (Cmax) of diazepam after intranasal VALTOCO administered to subjects with epilepsy 2 to 5 years of age | 0-6 hours |
Countries
United States
Outcome results
None listed