Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

Epilepsy Clinical Trial

Official title:

An Open-Label, Single-Dose, Pharmacokinetics Study of VALTOCO® With Open-Label Safety Period in Pediatric Subjects With Epilepsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05076838
• Other study ID #: DIAZ.001.08
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 8, 2021
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Neurelis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Missouri Women & Children's Hospital	Columbia	Missouri
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Duke University Hospital	Durham	North Carolina
United States	Northwest Florida Clinical Research Group, LLC.	Gulf Breeze	Florida
United States	Northeast Regional Epilepsy Group	Hackensack	New Jersey
United States	Boston Children's Health Physicians	Hawthorne	New York
United States	Le Bonheur Children's Hospital	Memphis	Tennessee
United States	Nicklaus Children's Hospital	Miami	Florida
United States	Center for Rare Neurological Diseases	Norcross	Georgia
United States	Children's Hospital of the King's Daughters	Norfolk	Virginia
United States	AdventHealth Research Institute	Orlando	Florida
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Neurelis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax) of diazepam after intranasal VALTOCO administered to subjects with epilepsy 2 to 5 years of age		0-6 hours