Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

Sponsor
Neurelis, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05076838
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
14
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Diazepam Nasal Spray [Valtoco]
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Single-Dose, Pharmacokinetics Study of VALTOCO® With Open-Label Safety Period in Pediatric Subjects With Epilepsy
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Maximum Plasma Concentration (Cmax) of diazepam after intranasal VALTOCO administered to subjects with epilepsy 2 to 5 years of age [0-6 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 5 Years
Sexes Eligible for Study:
All
Accepts 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 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Children's Hospital of The King's DaughtersNorfolkVirginiaUnited States23507

Sponsors and Collaborators

  • Neurelis, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Neurelis, Inc.
ClinicalTrials.gov Identifier:
NCT05076838
Other Study ID Numbers:
  • DIAZ.001.08
First Posted:
Oct 13, 2021
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021