Back to resultsPharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Diazepam Nasal Spray [Valtoco]
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
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.
Sites / Locations
- Northwest Florida Clinical Research Group, LLC.Recruiting
- Nicklaus Children's HospitalRecruiting
- AdventHealth Research InstituteRecruiting
- Center for Rare Neurological DiseasesRecruiting
- Massachusetts General Hospital
- University of Missouri Women & Children's HospitalRecruiting
- Northeast Regional Epilepsy GroupRecruiting
- Boston Children's Health PhysiciansRecruiting
- University of RochesterRecruiting
- Duke University HospitalRecruiting
- Le Bonheur Children's HospitalRecruiting
- UT Southwestern Medical Center
- Children's Hospital of the King's DaughtersRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Valtoco In Pediatric Subjects with Epilepsy
Arm Description
5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight.
Outcomes
Primary Outcome Measures
Maximum Plasma Concentration (Cmax) of diazepam after intranasal VALTOCO administered to subjects with epilepsy 2 to 5 years of age
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05076838
Brief Title
Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy
Official Title
An Open-Label, Single-Dose, Pharmacokinetics Study of VALTOCO® With Open-Label Safety Period in Pediatric Subjects With Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurelis, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Valtoco In Pediatric Subjects with Epilepsy
Arm Type
Experimental
Arm Description
5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight.
Intervention Type
Drug
Intervention Name(s)
Diazepam Nasal Spray [Valtoco]
Intervention Description
5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cyndi Guerra
Phone
(973) 615-6258
Email
cguerra@neurelis.com
Facility Information:
Facility Name
Northwest Florida Clinical Research Group, LLC.
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Genei Bougher, APRN
Phone
850-934-1299
Email
Gbougher@nwflcrg.com
First Name & Middle Initial & Last Name & Degree
Ben Renfroe, M.D.
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marinellie Vega
Phone
305-968-5491
Email
Marinellie.vega@nicklaushealth.edu
First Name & Middle Initial & Last Name & Degree
Matt Lallas, M.D.
Facility Name
AdventHealth Research Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Calla Boatright, BSN, RN
Phone
407-303-5600
Ext
112-3143
Email
Calla.Boatright@adventhealth.com
First Name & Middle Initial & Last Name & Degree
Ki Lee, M.D., M.S.
Facility Name
Center for Rare Neurological Diseases
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Tarquinio, D.O.
Phone
207-590-6945
Email
daniel@rareneuro.com
First Name & Middle Initial & Last Name & Degree
Daniel Tarquinio, D.O.
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taylor Savage
Phone
617-726-6524
Email
TESavage@MGH.Harvard.edu
First Name & Middle Initial & Last Name & Degree
Louisa Vincent
Phone
(617) 726-6524
Email
LBVincent@MGH.Harvard.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Thiele, MD,PhD
Facility Name
University of Missouri Women & Children's Hospital
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Anderson, Ph.D.
Phone
607-353-0021
Email
Christopher.anderson@health.missouri.edu
First Name & Middle Initial & Last Name & Degree
Paul Carney, M.D.
Facility Name
Northeast Regional Epilepsy Group
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Butryn
Phone
201-296-6842
Email
lbutryn@epilepsygroup.com
First Name & Middle Initial & Last Name & Degree
Eric Segal, M.D.
Facility Name
Boston Children's Health Physicians
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Pena
Phone
914-768-3970
Email
ppena_ar@nymc.edu
First Name & Middle Initial & Last Name & Degree
Donika Zogejan
Phone
914-768-3970
Email
dzogejan@nymc.edu
First Name & Middle Initial & Last Name & Degree
Steven Wolf, M.D.
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cate Concannon
Phone
585-275-0404
Email
Cathleen.concannon@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Inna Hughes, M.D., Ph.D.
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gloria Piniero
Phone
919-613-0767
Email
gloria.piniero@duke.edu
First Name & Middle Initial & Last Name & Degree
Muhammad Zafar, M.D.
Facility Name
Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Misha Webb
Phone
901-287-5330
Email
misha.webb@lebonheur.org
First Name & Middle Initial & Last Name & Degree
James Wheless, M.D.
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly Lawrence
Phone
214-456-2463
Email
Holly.Lawrence@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Deepa Sirsi, M.D.
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamika Walker
Phone
757-668-6896
Email
Tamika.Walker@CHKD.org
First Name & Middle Initial & Last Name & Degree
Michael Strunc, M.D.
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy
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