Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-08

Study Completion Date

2025-03-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Diazepam Nasal Spray [Valtoco]

Intervention Type DRUG

5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No