Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan

Shire25 enrolled

Overview

The purpose of this study is to assess the efficacy, safety and pharmacokinetics of MHOS/SHP615 administered buccally in children with status epilepticus (convulsive) in a healthcare setting.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nervous System Diseases

Interventions

SHP615DRUG

SHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg).

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 216 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female participants whose corrected gestational age is greater than or equal to (\>=) 52 weeks (gestational weeks plus the number of weeks after birth) and less than (\<) 18 years (and weight greater than \[\>\] 5 kilogram \[kg\]), at the time of investigational product administration. If the participant's exact age is not known, the participant should be excluded. * Parent, guardian, or legally authorized representative (LAR) of the child provides informed consent (and assent, when applicable per Shire policy and country regulations) to participate in the study prior to participation in any protocol specific procedures. The participant may be prescreened by the investigator in their clinical practice and the parent, guardian, or LAR may sign informed consent before the participant presents to the healthcare setting for treatment of the seizure. * Participant with generalized tonic-clonic SE with seizures accompanied by loss of consciousness with any of the following characteristics persistent at the time of study drug administration: 1. Currently presenting with seizure (convulsive) activity and 3 or more convulsions within the preceding hour 2. Currently presenting with seizure (convulsive) and 2 or more convulsions in succession without recovery of consciousness 3. Currently presenting with a single seizure (convulsive) lasting \>=5 mins Exclusion Criteria: * Female participants who are pregnant, suspected to be pregnant, or nursing. * Subjects with major trauma, not necessarily restricted to the head, as the cause of the seizure. * Subjects with seizures due to illegal drug or acute alcoholic intoxication. * Subjects with known or suspected recurrent seizures due to illegal drug or alcohol withdrawal. * Subjects with history of seizures of psychogenic origin. * Subjects with seizures due to severe encephalitis or meningitis, as determined by the PI * Subjects with known history of hypersensitivities, non-responsiveness or contraindications to benzodiazepines (ie, clinically significant respiratory depression, severe acute hepatic failure, myasthenia gravis, syndrome of sleep apnea, glaucoma with closed angle, use of concomitant drugs determined by the investigator to have a contraindication to the use of benzodiazepines.) * Subjects with a known history of benzodiazepine abuse. * Subjects who, in the judgment of the healthcare provider, have not responded to previous administrations of midazolam systemic therapies, including Midafresa and/or Dormicum. * Subjects who need emergent surgical intervention and general anesthesia/intubation. * Subjects with significant hypotension and cardiac dysrhythmia (example \[eg\], atrioventricular \[AV\] block of second or third degree, VT \[ventricular tachycardia\]). * Subjects who have been receiving human immunodeficiency virus (HIV) protease inhibitors or HIV reverse transcriptase inhibitors. * Subjects with current hypoglycemia (glucose \<60 milligram per deciliter \[mg/dL\]) upon presentation at the hospital or healthcare setting. * Subjects with severe cerebral anoxia (except cerebral palsy), in the judgment of the healthcare provider. * Subjects have used an investigational product or been enrolled in a clinical study (including vaccine studies) that, in the investigator's opinion, may impact this Shire-sponsored study. * Subjects has received antiseizure medication prior to arrival in the healthcare setting. * Subjects has prior placement of a vagus nerve stimulator.

Locations (23)

Yamanashi Prefectural Central Hospital

Kofu, Fujimi, Japan

Outcomes

Primary Outcomes

Percentage of Participants With Response Rate

Response rate was defined as the percentage of participants with therapeutic success. Therapeutic success was defined as the cessation of visible seizure activity within 10 minutes with a sustained absence of visible seizure activity for 30 minutes following a single dose of MHOS/SHP615 without the need for additional rescue medication.

Time frame: From start of study drug administration up to 30 minutes post-dose

Secondary Outcomes

Percentage of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4 and 6 Hours

Percentage of participants whose seizure event stopped within 10 minutes of single dose administration of SHP615 and who had sustained absence of seizure activity for at least 1, 4, and 6 hours were reported.

Time frame: From start of study drug administration up to 1, 4 and 6 hours post-dose

Number of Participants With Time to Resolution of Seizures (Convulsions)

Time to resolution of seizures (convulsions) was calculated as time from IP administration to the end of the initial seizure or administration of rescue anti-convulsant medication, whichever occurs first. Initial seizure referred to the seizure that triggered the use of the IP. Number of participants with time to resolution of seizures (convulsions) from the administration of SHP615 were reported.

Time frame: From start of study drug administration up to follow-up (Day 8)

Number of Participants With Time to Recovery of Consciousness

Time to recovery of consciousness (in minutes) was calculated only for participants who lost consciousness pre-dose at time from investigational product administration to recovery of consciousness post-dose or administration of rescue anticonvulsant medication, whichever occurs first. Number of participants with time to recovery of consciousness were reported.

Time frame: From start of study drug administration up to follow-up (Day 8)

Data from ClinicalTrials.gov

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