Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy
- Registration Number
- NCT05076838
- Lead Sponsor
- Neurelis, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Valtoco In Pediatric Subjects with Epilepsy 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.
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of diazepam after intranasal VALTOCO administered to subjects with epilepsy 2 to 5 years of age 0-6 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Center for Rare Neurological Diseases
🇺🇸Norcross, Georgia, United States
Boston Children's Health Physicians
🇺🇸Hawthorne, New York, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Northwest Florida Clinical Research Group, LLC.
🇺🇸Gulf Breeze, Florida, United States
AdventHealth Research Institute
🇺🇸Orlando, Florida, United States
Nicklaus Children's Hospital
🇺🇸Miami, Florida, United States
Northeast Regional Epilepsy Group
🇺🇸Hackensack, New Jersey, United States
University of Missouri Women & Children's Hospital
🇺🇸Columbia, Missouri, United States
University of Rochester
🇺🇸Rochester, New York, United States