Acute Convulsive Seizures
Conditions
Interventions
Trade Name: Buccolam 2.5mg
Pharmaceutical Form: Oromucosal solution
INN or Proposed INN: MIDAZOLAM HYDROCHLORIDE
CAS Number: 59467-96-8
Current Sponsor code: SHP615
Concentration unit: mg milligram(s)
Sponsors
Shire
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female subjects with a corrected gestational age of =52 weeks (gestational weeks plus the number of weeks after birth) and 5 kg) at the time of IP administration (if the subject’s exact age was not known, the subject was to be excluded). • Parent, guardian, or legally authorized representative of the child provided 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 subject may have been prescreened by the investigator in their clinical practice and the parent, guardian, or legally authorized representative may have signed informed consent before the subject presented to the healthcare setting for treatment of the seizure. • Subjects with generalized tonic clonic status epilepticus (SE) with seizures accompanied by loss of consciousness with any of the following characteristics persistent at the time of IP administration: • Presented, at the time, with seizure (convulsive) activity and 3 or more convulsions within the preceding hour • Presented, at the time, with seizure (convulsive) and 2 or more convulsions in succession without recovery of consciousness • Presented, at the time, with a single seizure (convulsive) lasting =5 minutes. Are the trial subjects under 18? yes Number of subjects for this age range: 25 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Female subjects who were 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 cases of encephalitis or meningitis, as determined by the investigator. • Subjects with known history of hypersensitivities, nonresponsiveness 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, had not responded to previous administrations of midazolam systemic therapies, including Midafresa® and/or Dormicum®. • Subjects who needed emergency surgical intervention and general anesthesia/intubation. • Subjects with significant hypotension and cardiac dysrhythmia (eg, atrioventricular block of second or third degree, ventricular tachycardia). • Subjects who had been receiving human immunodeficiency virus (HIV) protease inhibitors or HIV reverse transcriptase inhibitors. • Subjects with current hypoglycemia (glucose <60 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 had used an IP or been enrolled in a clinical study (including vaccine studies) that, in the investigator’s opinion, may impact this Shire-sponsored study. • Subject had received antiseizure medication prior to arrival in the healthcare setting. • Subject had prior placement of a vagus nerve stimulator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy of MHOS/SHP615 administered buccally in pediatric patients with status epilepticus (convulsive) in a healthcare setting.;Secondary Objective: The secondary objectives of this study are to assess the safety and pharmacokinetics of MHOS/SHP615 administered buccally to pediatric patients with status epilepticus (convulsive) in a healthcare setting.;Primary end point(s): Response rate, which is defined as the percentage of subjects with therapeutic success ;Timepoint(s) of evaluation of this end point: From start of study drug administration to follow-up (8 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percentage of subjects whose seizure event(s) stopped within 10 minutes of a single dose of SHP615 and who have sustained absence of seizure activity for 1, 4, 6 hours • Time to resolution of seizures • Time to recovery of consciousness • Percentage of subjects who fail to respond to treatment • Respiratory depression • Aspiration pneumonia • Sedation or agitation as measured by the Riker Sedation-Agitation Scale • Incidences/monitoring of treatment-emergent adverse events (TEAEs) • Occurrence of buccal irritation • Pharmacokinetics;Timepoint(s) of evaluation of this end point: From start of study drug administration to follow-up (8 days) | — |
Countries
Japan
Contacts
Public ContactClinical Transparency
Shire
Outcome results
None listed