JPRN-jRCT2071230030招募中2 期
A Phase II Study of NPC-15 -Investigation of the Efficacy and Safety of NPC-15 on Difficulty Initiating Sleep in Patients with Dementia - NPC-15-12
Motomura Tomoko0 个研究点目标入组 120 人开始时间: 2023年6月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
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
- 年龄范围
- >= 60age old 至 <= 84age old（—）
- 性别
- All
入选标准
- •(1) A patient aged from 60 to 84 years at the time of obtaining informed consent.
- •(2) A patient who meets diagnostic criteria for dementia in DSM-5.
- •(3) A patient whose usual averaged sleep onset latency (time to falling asleep from bedtime) of 30 minutes or longer continues for 3 months or longer at the time of informed consent.
- •(4) A patient who is able to visit the hospital as scheduled.
- •(5) A patient is an outpatient.
- •(6) A patient who participates in the study voluntarily, and gives written informed consent.
排除标准
- •(1) A patient who has a past history to ingest melatonin including its supplements for more than 1 week.
- •(2) A patient who has a past history of hypersensitivity or allergy to melatonin or ramelteon.
- •(3) A patient who has hepatic dysfunction (AST>100 U/L or ALT>100 U/L).
- •(4) A patient who has received prohibited concomitant medications (including OTC drugs or supplements for melatonin) or has started to receive instructions/therapies for improving sleep within 4 weeks prior to the start of the Screening period, or requires those medications or the start of those during the study period.
- •(5) A patient who has started to receive restricted concomitant medications or restricted therapies (cognitive behavioral therapy or bright light therapy) within 4 weeks prior to the start of the Screening period, or is scheduled to start such medications or treatments during the study period.
- •(6) A patient who is not able to refrain from ingesting beverage containing caffeine (up to 3 cans/cups a day) and alcoholic beverage (up to around 180 mL of Japanese sake or equivalent a day)
- •(7) A patient who is scheduled to have stay out overnight during the study period.
- •(8) A patient who needs to operate dangerous machinery during the study period.
- •(9) A patient who has participated in a clinical study or post marketing clinical study and received the study drug (including placebo) or participated in a clinical study or post marketing clinical study for medical devices within 4 months prior to the start of the Screening period.
- •(10) A patient who has participated in a clinical investigation involving invasive examinations within 4 months prior to the start of the Screening period.
- •(11) A female patient who is presently pregnant or breast-feeding, or willing to be pregnant and not to consent to contraception between the informed consent and completion of the study.
- •(12) A patient who is receiving fluvoxamine maleate or may receive the drug during the study period.
- •(13) A patient who has a significant disease or findings to be inappropriate to participate in the study according to the opinion of the investigator or sub-investigator.
研究者
相似试验
招募中
2 期
A phase II study of NPC-15 on difficulty initiating sleep in patients with mild cognitive impairmentJapanese patients with mild cognitive impairment who has difficulty initiating sleepJPRN-jRCT2071230029Motomura Tomoko120
进行中（未招募）
2 期
A Phase IIB, Randomized, Double Blinded, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants With a Prior Myocardial Infarction and Persistent InflammatioCoronary Heart Disease (CHD)JPRN-jRCT2021200037Hibi Kazushige84
已完成
2 期
A Phase II Trial to Assess the Activity of NY-ES-O1 Targeted T Cells in Advanced Oesophagogastric CancerCancerISRCTN83343031Christie Hospital NHS Foundation Trust (UK)28
进行中（未招募）
1 期
A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas aeruginosa. - EVADEPrevention of nosocomial pneumonia caused by Pseudomonas aeruginosaMedDRA version: 20.0Level: LLTClassification code 10051190Term: Pneumonia Pseudomonas aeruginosaSystem Organ Class: 100000004862EUCTR2015-001706-34-HUMedImmune, LLC188
进行中（未招募）
1 期
Clinical trial looking at the safety and efficacy of MEDI3902 in the prevention of Pseudomonas aeruginosa pneumonia occurring in the hospitalPrevention of nosocomial pneumonia caused by Pseudomonas aeruginosaMedDRA version: 18.1Level: LLTClassification code 10051190Term: Pneumonia Pseudomonas aeruginosaSystem Organ Class: 100000004862EUCTR2015-001706-34-DEMedImmune, LLC429