JPRN-jRCT2080224694已完成3 期
A Phase 3, Multicenter, Open-label Extension Study of Buccally Administered MHOS/SHP615 in Pediatric Patients With Status Epilepticus (Convulsive) in Community Settings
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3
研究概览
简要总结
Buccal administration of an age-stratified dose of MHOS/SHP615 for the management of SE in a community setting was effective and well tolerated in all subjects who received treatment to date.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 6month old 至 <= 18age old（—）
- 性别
- All
入选标准
- •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 (<) 18 years of age at the time of investigational product administration. If the subject's exact age is not known, the subject should be excluded.
- •Parent, guardian, or legally authorized representative of the child who provides informed consent and assent (when applicable) to participate in the study after initial stabilization of the subject with SE in hospital or emergency room during the SHP615-301 study. The subject also provides informed consent prior to participation, where applicable.
- •Parent, guardian, or legally authorized representative who have received appropriate training/education and are deemed qualified by the investigator and are willing to:
- •- Properly administer MHOS/SHP615- Record seizure information and dosing of MHOS/SHP615 in a subject diary (including time of seizure onset, type of seizure, time necessary to administer MHOS/SHP615, time between MHOS/SHP615 administration to seizure cessation, etc.)
- •- Follow the necessary instructions to secure the safety of the subject
- •Subjects who experience 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) persisting >= 5 minutes
排除标准
- •- 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
研究者
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