Submission of Clinical Study Result for Pediatric Study SHP 615 - 302
- Conditions
- Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children, and adolescents (from 3 months to < 18 years)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2021-002051-10-Outside-EU/EEA
- Lead Sponsor
- Takeda Development Center, Americas (TDC Americas)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method