Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

Sponsor

Neurelis, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05076838

Collaborator

(none)

Enrollment

Locations

Arm

18.7

Anticipated Duration (Months)

3.3

Patients Per Site

0.2

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 Disease	Intervention/Treatment	Phase
Epilepsy	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

Actual Study Start Date :

Nov 8, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwest Florida Clinical Research Group, LLC.	Gulf Breeze	Florida	United States	32561
2	AdventHealth Research Institute	Orlando	Florida	United States	32803
3	Center for Rare Neurological Diseases	Norcross	Georgia	United States	30093
4	University of Missouri Women & Children's Hospital	Columbia	Missouri	United States	65201
5	Northeast Regional Epilepsy Group	Hackensack	New Jersey	United States	07601
6	Boston Children's Health Physicians	Hawthorne	New York	United States	10532
7	University of Rochester	Rochester	New York	United States	14623
8	Le Bonheur Children's Hospital	Memphis	Tennessee	United States	38105
9	Children's Hospital of the King's Daughters	Norfolk	Virginia	United States	23507

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:

Jun 21, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Epilepsy

Diazepam

Study Results

No Results Posted as of Jun 21, 2022