Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children, and adolescents (from 3 months to < 18 years)
Conditions
Interventions
Trade Name: Buccolam oromucosal solution
Pharmaceutical Form:
INN or Proposed INN: MIDAZOLAM
CAS Number: 59467-70-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concent
Sponsors
Takeda Development Center, Americas (TDC Americas)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects who completed the SHP615-301 study and who tolerated and responded to treatment with MHOS/SHP615 in the hospital and/or emergency room and were considered stable for discharge from the hospital. - Subjects who were more than 6 months and less than 18 years of age at the time of MHOS/SHP615 administration. If the subject's exact age was not known, the subject was excluded. -Subjects who experienced 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: Presented, at the time, with seizure (convulsive) activity and 3 or more convulsions within the preceding hour;in succession without recovery of consciousness or presented, at the time, with a single seizure (convulsive) persisting =5 minutes. Are the trial subjects under 18? yes Number of subjects for this age range: 6 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 major trauma, not necessarily restricted to the head, as the cause of the seizure. - Subjects with known or suspected recurrent seizures due to illegal drug or alcohol withdrawal. - Subjects with seizures due to illegal drug or acute alcoholic intoxication - Subjects with seizures of psychogenic origin - Subjects with seizures due to severe cases of encephalitis or meningitis, as determined by the investigator. - Subjects with a 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, or 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 had not responded to previous administrations of midazolam systemic therapies, including Midafresa and/or Dormicum. - Subjects who needed emergent surgical intervention and general anesthesia/intubation. - Subjects who had been receiving human immunodeficiency virus (HIV) protease inhibitors or HIV reverse transcriptase inhibitors. Subjects with severe cerebral anoxia (except cerebral palsy), in the judgment of the healthcare provider. Had used an IP or been enrolled in a clinical study (including vaccine studies) that, in the investigator’s opinion, may impact this TDC Americas-sponsored study. Subject had prior placement of a vagus nerve stimulator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study was to assess the efficacy of buccally administered midazolam hydrochloride oromucosal solution (MHOS/SHP615) in pediatric subjects with status epilepticus (SE; convulsive) in the community setting. ;Secondary Objective: The secondary objective of this study was to assess the safety of buccally administered MHOS/SHP615 in pediatric subjects with SE (convulsive) in the community setting. ;Primary end point(s): Seizure to stop after administration of Bucolam;Timepoint(s) of evaluation of this end point: Seizure to stop within 10 minutes after administration of Bucolam | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No seizures to be observed after administration;Timepoint(s) of evaluation of this end point: No seizures to be observed during the first hour after administration | — |
Countries
Japan
Contacts
Public ContactClinical Trial Information
Laboratorios Lesvi
Outcome results
None listed