A Pilot Parallel Double-Blind, Randomized Trial of Galantamine for Subarachnoid Hemorrhage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug
研究概览
简要总结
The purpose of this study is to examine the effects of the study drug--Galantamine-on patients with subarachnoid hemorrhage (SAH). The study will examine how patients with SAH will tolerate the study drug and how it may improve brain functioning in patients after SAH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spontaneous subarachnoid hemorrhage
- •Presentation to hospital within 72 hours of symptoms
- •Fisher grade 3 hemorrhage (thick subarachnoid clot) on initial computed tomography (CT) scan
- •Hunt and Hess grade 1-5 at time of randomization
- •Presence of a cerebral aneurysm on computed tomographic angiography (CTA) or Angiogram for which clipping or coiling is possible
- •Ability to obtain medication within 36 hours of presentation
排除标准
- •subarachnoid hemorrhage (SAH) due to causes other than aneurysm rupture (trauma, arteriovenous malformation (AVM), mycotic aneurysms, Moyamoya)
- •Pre-existing disability with modified Rankin Scale (mRS) score ≥2,
- •Renal disease as defined by creatinine clearance less than 9 milliliters/min
- •History of severe hepatic impairment (Child-Pugh score of 10-15)
- •History of chronic obstructive pulmonary disease (COPD) or asthma
- •History of dementia
- •Co-morbid conditions likely to complicate therapy, including clinically significant arrhythmia, acquired immune deficiency syndrome (AIDS), autoimmune disease, malignancy, and expected mortality within 72 hours
- •Expected mortality within 72 hours as determined by PI, treating neurointensivist and neurosurgeon. (Clinically manifested by no attempt at securing aneurysm)
- •Females who are pregnant.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
8mg galantamine twice daily
干预措施: 8mg galantamine twice daily (Drug)
12mg galantamine twice daily
干预措施: 12mg galantamine twice daily (Drug)
结局指标
主要结局
Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug
时间窗: 90 days
Mortality
时间窗: 90 days
Modified Rankin Score
时间窗: 90 days
The Modified Rankin Score (mRS) is scored as follows: 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.
次要结局
- Montreal Cognitive Assessment (MoCA)(90 days)
- EuroQOL Score as Assessed by a Visual Analogue Scale (VAS)(90 days)
研究者
HuiMahn Alex Choi
Assistant Professor
The University of Texas Health Science Center, Houston