Status Epilepticus (Convulsive)
Conditions
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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 (] 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 pre-screened 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: - Currently presenting with seizure (convulsive) activity and 3 or more convulsions within the preceding hour - Currently presenting with seizure (convulsive) and 2 or more convulsions in succession without recovery of consciousness - Currently presenting with a single seizure (convulsive) lasting 5 minutes or longer.
Exclusion criteria
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 (e.g. atrioventricular block of second or third degree, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percentage of Participants With Therapeutic Success: Therapeutic success will be 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 SHP615. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 1. Percentage of Participants Whose Seizure Event Stopped Within 10 Minutes of Single Dose of SHP615 and who Have Sustained Absence of Seizure Activity for at least 1 Hour efficacy 2. Percentage of Participants Whose Seizure Event Stopped Within 10 Minutes of Single Dose of SHP615 and who Have Sustained Absence of Seizure Activity for at least 4 Hours efficacy 3. Percentage of Participants Whose Seizure Event Stopped Within 10 Minutes of Single Dose of SHP615 and who Have Sustained Absence of Seizure Activity for at least 6 Hours efficacy 4. Time to resolution of seizures (Convulsions) efficacy 5. Time to Recovery of Consciousness efficacy 6. Percentage of Participants who Require Additional Anticonvulsant Medication for Ongoing status epilepticus (SE) 10 Minutes After Single Dose Administration of SHP615 efficacy 7. Percentage of Participants who Fail to Respond to Treatment [Time Frame: 10 mins post-dose]: Treatment failure or non-responder is defined as continuing seizure activity and/or the need for any additional rescue medication according to the participating healthcare setting protocol or guideline, 10 mins after a single dose of SHP615. efficacy 8. Respiratory Depression [Time Frame: Baseline up to 24 h post-dose]: Persistent decrease in oxygen saturation to <92% measured at 10, 30 min, and 4, 6, and 24 hours post-dose (i.e. <92% on room air for 2 minutes or more after dosing while monitoring [per healthcare setting protocol and/or the clinical judgment of the physician]). efficacy 9. Number of Participants With Aspiration Pneumonia Reported as Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From start of study drug administration up to follow-up (Day 8) ] TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product and no later than 3 days following the last dose of IP. Number of participants with aspiration pneumonia identified as TEAEs were reported. efficacy 10. Sedation or Agitati | — |
Countries
Japan
Outcome results
None listed