Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

Overview

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.

Full Title of Study: “An Open-Label, Single-Dose, Pharmacokinetics Study of VALTOCO® With Open-Label Safety Period in Pediatric Subjects With Epilepsy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2022

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Valtoco In Pediatric Subjects with Epilepsy
    • 5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject’s body weight.

Clinical Trial Outcome Measures

Primary Measures

  • Maximum Plasma Concentration (Cmax) of diazepam after intranasal VALTOCO administered to subjects with epilepsy 2 to 5 years of age
    • Time Frame: 0-6 hours

Participating in This Clinical Trial

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 are used at least once per month for the last 3 months. Exclusion Criteria:

  • Subjects whose body weight are < 6 kg or > 33 kg. – Subject is undergoing intracranial electroencephalogram (EEG) monitoring. – A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, severe seasonal or non-seasonal allergies, nasal polyps or any nasal passage abnormality. – 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.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Neurelis, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Cyndi Guerra, (973) 615-6258, cguerra@neurelis.com

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