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Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05076838
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : January 27, 2022
Sponsor:
Information provided by (Responsible Party):
Neurelis, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 8, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Diazepam

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.




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 are used approximately 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076838


Contacts
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Contact: Cyndi Guerra (973) 615-6258 cguerra@neurelis.com

Locations
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United States, Florida
Northwest Florida Clinical Research Group, LLC. Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Genei Bougher, APRN         
Principal Investigator: Ben Renfroe, M.D.         
United States, Georgia
Center for Rare Neurological Diseases Recruiting
Norcross, Georgia, United States, 30093
Contact: Daniel Tarquinio, D.O.         
Principal Investigator: Daniel Tarquinio, D.O.         
United States, Missouri
University of Missouri Women & Children's Hospital Recruiting
Columbia, Missouri, United States, 65201
Contact: Paul Carney, MD    573-882-6882    prcarney@health.missouri.edu   
Principal Investigator: Paul Carney, MD         
United States, New Jersey
Northeast Regional Epilepsy Group Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Linda Butryn         
Principal Investigator: Eric Segal, M.D.         
United States, New York
Boston Children's Health Physicians Recruiting
Hawthorne, New York, United States, 10532
Contact: Patricia Pena       ppena_ar@nymc.edu   
Contact: Donika Zogejan       dzogejan@nymc.edu   
Principal Investigator: Steven Wolf, MD         
University of Rochester Recruiting
Rochester, New York, United States, 14623
Contact: Cate Concannon       Cathleen.concannon@urmc.rochester.edu   
Principal Investigator: Inna Hughes, MD, PhD         
United States, Tennessee
Le Bonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Misha Webb       misha.webb@lebonheur.org   
Principal Investigator: James Wheless, MD         
United States, Virginia
Children's Hospital of The King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Michael Strunc, M.D.         
Principal Investigator: Michael Strunc, M.D.         
Sponsors and Collaborators
Neurelis, Inc.
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Responsible Party: Neurelis, Inc.
ClinicalTrials.gov Identifier: NCT05076838    
Other Study ID Numbers: DIAZ.001.08
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Diazepam
Adjuvants, Anesthesia
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action