A Randomized, Double-Blind, Placebo Controlled Trial Examining the Safety and Efficacy of Midazolam Intranasal Spray (USL261) for the Treatment of Intermittent Bouts of Increased Seizure Activity in the Epilepsy Monitoring Unit (EMU) - ARTEMIS EM

psher-Smith Laboratories, Inc.0 个研究点目标入组 62 人开始时间: 2015年1月23日最近更新: 2015年10月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 62

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•A subject will be eligible for enrollment in the study if all of the following criteria apply:
•1.The subject or the subject’s legally acceptable representative (LAR) has provided written informed consent, and subject has provided written assent where required by local law or Institutional Review Board (IRB)/Independent Ethics Committee (IEC) policy
•2.Subject has been admitted to the institution’s EMU for seizure characterization or pre-surgical evaluation, or such admission is planned within 28 days
•3.Subject body weight is = 40 kg to = 125 kg (inclusive)
•4.Subject is = 12 years of age at Screening
•5.Subject has an established diagnosis of partial or generalized epilepsy
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 10
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

排除标准

•1.Subject has a medical condition that could interfere with the absorption or pharmacokinetics of USL261
•2.Subject has history of status epilepticus in the 6 months prior to screening
•3.Subject has a progressive neurological disorder such as brain tumor, demyelinating disease, or degenerative central nervous system (CNS) disease that is likely to progress in the next 12 months
•4.Subject has a positive alcohol test or a positive urine drug screen (UDS) not associated with documented legitimate medical use. Individuals with cognitive disability that precludes the collection of a urine sample by conventional means are exempt from the screening UDS requirement provided that the subject is deemed unlikely to have been recently exposed to drugs of abuse based on the opinion of the investigator and the reason the urine could not be obtained is documented
•5.Subject has respiratory failure (or is at risk for respiratory failure) or other severe cardio-respiratory disease with New York Heart Association Class III or IV functional status, or requires supplemental oxygen
•6.Subject has acute narrow-angle glaucoma
•7.Subject (females only) has a positive pregnancy test during the Screening Phase or is currently pregnant or breastfeeding at time of Screening or time of admission to the EMU
•8.Subject has a prior history of any significant adverse reactions (including rash) to benzodiazepines or known allergies to midazolam or formulation components
•9.Subject requires concomitant treatment with any of the prohibited substances listed in this protocol (including strong CYP3A4 inhibitors or respiratory depressants), or cannot safely discontinue prohibited substances with sufficient washout prior to the Treatment Phase (See Appendix 1)
•10.Subject is receiving chronic benzodiazepine treatment (defined as an average of = 4 administrations per week) and cannot safely withdraw from such treatment within the washout period prior to the Treatment Phase. The management of safe withdrawal of benzodiazepine therapy is left to the discretion of the investigator. Benzodiazepines that are used for rescue therapy of seizures or for non-epilepsy indications are allowed provided they are typically used = 3 times in a 7-day period
•11.Subject has any clinically significant laboratory abnormality as determined by the investigator at Screening
•12.Subject has any clinically significant 12-lead electrocardiogram (ECG) findings as determined by the investigator at Screening
•13.Subject has any clinically significant abnormal vital sign values as determined by the investigator at Screening
•14.Subject is currently using an investigational drug or device or has used such within the 60 days prior to the Screening Phase. The use of experimental non-interventional devices such as seizure detection devices is not considered exclusionary.
•15.Subject has previously participated in a study of USL261
•16.Subject has any condition that may interfere with subject safety/safety monitoring, or preclude the safe administration of a benzodiazepine, or is not appropriate for the study for any other reason as determined by the investigator.

研究者

发起方

psher-Smith Laboratories, Inc.

相似试验

已完成

2 期

Effect of Ashwagandha on the Immunity of Healthy Participants

CTRI/2018/07/014792Arjuna Natural Ltd24

进行中（未招募）

不适用

Clinical Trial to evaluate the efficacy, safety and tolerability of Midazolam Intranasal Spray compared with a placebo administered through the nose (intranasal) for the treatment of intermittent bouts of increased seizure in a site that monitors epilepsy.MedDRA version: 17.1Level: LLTClassification code 10015052Term: Epileptic seizureSystem Organ Class: 100000004852Epilepsy

EUCTR2014-003961-49-ITpsher-Smith Laboratories, Inc.62

进行中（未招募）

不适用

EUCTR2014-003961-49-ATpsher-Smith Laboratories, Inc.62

进行中（未招募）

1 期

EUCTR2014-003961-49-CZpsher-Smith Laboratories, Inc.62

进行中（未招募）

1 期

A Clinical Trial Examining the Effects of Temelimab Following Rituximab Treatment in Patients with Multiple SclerosisMedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMultiple Sclerosis

EUCTR2019-004822-15-SEGeNeuro Innovation SAS40