Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

November 20, 2023 updated by: Neurelis, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Northwest Florida Clinical Research Group, LLC.
      • Miami, Florida, United States, 33155
        • Nicklaus Children's Hospital
      • Orlando, Florida, United States, 32803
        • AdventHealth Research Institute
    • Georgia
      • Norcross, Georgia, United States, 30093
        • Center for Rare Neurological Diseases
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Missouri
      • Columbia, Missouri, United States, 65201
        • University of Missouri Women & Children's Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Northeast Regional Epilepsy Group
    • New York
      • Hawthorne, New York, United States, 10532
        • Boston Children's Health Physicians
      • Rochester, New York, United States, 14623
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • Le Bonheur Children's Hospital
    • Texas
      • Dallas, Texas, United States, 75225
        • UT Southwestern Medical Center
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Children's Hospital of The King's Daughters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0-6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurelis, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2021

Primary Completion (Actual)

August 31, 2023

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIAZ.001.08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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