EUCTR2011-001318-32-HU进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study ofthe Safety and Efficacy of Intranasal Midazolam (USL261) inthe Outpatient Treatment of Subjects with Seizure ClustersARTEMIS-1: Acute Rescue Therapy in Epilepsy withMidazolam Intranasal Spray-1 - ARTEMIS-1: Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray-1
psher-Smith Laboratories, Inc.0 个研究点目标入组 350 人开始时间: 2012年4月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Subject or 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/Independent Ethics Committee policy
- •Subject has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes
- •Subject is 12 years of age or older, at Visit 1
- •Subject has an established diagnosis of partial or generalized epilepsy that includes all of the following:
- •- A documented history of seizure clusters lasting a minimum of 10 minutes from the time the seizure cluster is recognized
- •- The seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any) in seizure type, duration, severity or frequency
- •- As part of the subject's stereotyped seizure cluster pattern, a second seizure typically occurs within 6 hours from the time of recognition of the seizure cluster
- •- In the investigator's opinion, it would be safe for the subject to receive placebo as a first dose of study drug followed by active treatment (USL261) as the second dose of study drug no earlier than 10 minutes after the first dose
- •- The subject's stereotyped seizure cluster pattern is composed of multiple (=2) partial or generalized seizures
- •- The subject's stereotyped seizure cluster pattern was established > 3 months before Visit 1
- •- A frequency of =3 stereotyped seizure clusters during the year before Visit 1
- •- At least 1 stereotyped seizure cluster occurring =4 months before Visit 1
- •- The seizure cluster pattern described above is confirmed by a central reviewer
- •Currently on a stable regimen of AEDs since Visit 1 and for =7 days before Visit 2.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 283
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •Subject has a neurological disorder that is likely to progress in the next year
- •Subject has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
- •Subject has a history of their stereotypical seizure cluster progressing to status epilepticus (as determined by the investigator) within the 2 years before Visit 1
- •Subject has acute narrow-angle glaucoma.
- •Subject has had an active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 as defined by a Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation score =3, any suicide attempt in the past 5 years as determined by the C-SSRS or medical history, or other clinically significant suicidality as determined by the investigator
- •Subject is currently using a vagal nerve stimulator (VNS) unless the device has been implanted for at least 6 months and the settings have not changed within 4 weeks before Visit 1.
研究者
相似试验
进行中（未招募）
1 期
This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD)Subjects with moderately to severely active Crohn's diseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2021-002869-18-BEAbbVie Deutschland GmbH & Co. KG265
进行中（未招募）
1 期
Clinical Trial to compare if seriously-ill adults with constipation due to narcotics have bowel movements sooner after injection with Methylnatrexone or placeboEUCTR2007-000854-30-BESalix Pharmaceuticals Inc254
进行中（未招募）
不适用
A study to evaluate the effect and safety of a 4 week treatment plan of Alirocumab in patients with high cholesterolPrimary HypercholesterolemiaMedDRA version: 17.0Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861EUCTR2013-002343-29-GBRegeneron Pharmaceuticals, Inc.803
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Markers of Intravascular Inflammation in Subjects with Coronary Artery Disease - E5555-G000-201Coronary Artery DiseaseMedDRA version: 8.1Level: PTClassification code 10011078EUCTR2005-006029-94-BEEisai Limited720
已完成
不适用
A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Male Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of JNJ-26070109abdominal pain and heartburn10017943NL-OMON30044Janssen-Cilag82