Status Epilepticus (Convulsive)
Conditions
Sponsors
Takeda Pharmaceutical Company Limited
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 are considered stable for discharge from the hospital. Subjects who are greater than (>) 6 months and less than (= 5 minutes
Exclusion criteria
Exclusion criteria: - Female subjects 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 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 known history of hypersensitivities, nonresponsiveness or contraindications to benzodiazepines (that is (i.e.), 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 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 who have 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 - 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 - Subject has prior placement of a vagus nerve stimulator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Efficacy: Number of Participants With Therapeutic Success Time Frame: From start of study drug administration up to 30 minutes post-dose Therapeutic success was defined as cessation of visible seizure activity within 10 minutes and sustained absence of visible seizure activity for 30 minutes following a single dose of SHP615 without the need for additional rescue medication. Number of participants with therapeutic success were reported. safety Safety: Number of Participants With Respiratory Depression Time Frame: Up to 24 hours post-dose Respiratory depression, included the following measures within 24 hours after administration of the IP: i) Persistent decrease in oxygen saturation to <92 percent (%) measured at 1 hour, 4 hours, 6hours, 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]. ii) Increase in respiratory effort such that assisted ventilation is used (bag-valve-mask ventilation or endotracheal intubation). Number of participants with respiratory depression were reported. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Efficacy: Number of Participants Who Had Sustained Absence of Seizure Activity for at Least 1, 4, and 6 Hours Time Frame: From start of study drug administration up to 1, 4, and 6 hours post-dose Number 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. efficacy Efficacy: Time to Resolution of Seizures (Convulsions) Time Frame: From start of study drug administration up to follow-up (Day 8) Time to resolution of seizures (convulsions) was calculated as time from SHP615 administration to the end of the initial seizure or administration of rescue anticonvulsant medication, whichever occurs first. The initial seizure refers to the seizure which triggered the use of the IP. Participant wise data was reported for this outcome. efficacy Efficacy: Time to Recovery of Consciousness Time Frame: From start of study drug administration up to follow-up (Day 8) Time to recovery of consciousness in minutes was calculated only for participants who lost consciousness pre-dose as time from SHP615 administration to recovery of consciousness post-dose or administration of rescue anticonvulsant medication, whichever occurs first. Participant wise data was reported for this outcome. efficacy Efficacy: Percentage of Participants Who Required Additional Anticonvulsant Medication for Ongoing Status Epilepticus (SE) 10 Minutes After Administration of SHP615 Time Frame: 10 minutes post-dose Percentage of participants who required additional anticonvulsant medication for ongoing SE according to the participating hospital protocol or guideline, 10 minutes after the administration of SHP615 were reported. efficacy Efficacy: Percentage of Participants Who Failed to Respond to Treatment With SHP615 Time Frame: 10 minutes post-dose Treatment failure/non-responder was defined as continuing seizure activity and/or the need for any additional | — |
Countries
Japan
Outcome results
None listed