Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania (MAMBO)
MAMBO: Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania
研究概览
详细说明
This is a prospective, phase II study of fluoxetine for motor recovery post-stroke in adults with new-onset ischemic stroke in urban Tanzania. Participants will be enrolled at the Muhimbili National Hospital (MNH) in Dar Es Salaam after confirmation of exclusion and inclusion criteria, including a head CT. Participants will be enrolled within 21 days of acute, ischemic stroke. The study will utilize a novel method for monitoring patient medication adherence: electronic pill bottles that can record medication use events. The primary goals of this study are to assess the safety and tolerability of fluoxetine post-stroke to evaluate the feasibility of conducting a larger, phase III study in the future.
Vital status will be monitored throughout the study's enrollment period. At enrollment, participants will have cognitive tests administered, receive lumbar puncture, and receive an MRI brain. After discharge from the hospital, participants will be seen at 30-, 60-, and 90-days post-enrollment for an in-person study visit. At each time point, investigators will draw 10-15 mL of blood; download medication adherence data from participants' electronic pill bottles; and inquire about adverse events and evaluate patient disability through the modified Rankin Scale. If participants stop taking their daily pill, stroke specific reasons for non-adherence will be inquired including dysphagia, self-administration, and other concerns.
Primary assessments will be for safety and tolerability, as well as measurement of the Fugl-Meyer Motor Scale. Medication use data will also be collected through the electronic pill bottle, which will be returned to study investigators. As secondary assessments, the PHQ-9, and the Asberg Depressive Symptom Questionnaire will be administered. All 90-day assessments will be administered by senior site investigators, who will take a final 10-15mL blood draw to test for serum sodium and liver enzymes, possible adverse events related to long-term fluoxetine use, conduct a second MRI brain, evaluate participant mRS, and inquire about tolerability issues. Completion of the 90-day visit and associated assessments is considered the study endpoint.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Dar es Salaam、坦桑尼亚
- Muhimbili National Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participant is 18 years of age or older
- Participant has experienced a CT-confirmed ischemic stroke w/in 21 days of enrollment
Exclusion Criteria:
- NIH Stroke Scale Score >20 points
- Unconscious at presentation
- Hemorrhagic conversion of ischemic infarct
- transient ischemic symptoms <24h,
- Current antidepressant or psychoactive drug use (e.g. SSRI, monoxidase amine inhibitor, benzodiazepine).
- Current pregnancy.
- History of recent head trauma.
- Baseline motor deficits from other etiologies including prior stroke.
- Dysphagia preventing the swallowing of a pill.
- Hyponatremia (<125 mmol/L), hepatic impairment as defined by a serum alanine aminotransferase (ALT) of >120 U/L.
- Renal impairment as defined by a creatinine >180 micromol/L or GFR <30mL/min/1.73m2.
- Patients who are moribund for other reasons and unlikely to survive to 90 days will also be excluded from participation.
- Contraindication to MRI (e.g. piercings/tattoos, electronic/metallic implants, claustrophobia)
- Contraindication to lumbar puncture (e.g. infection at site of needle insertion, evidence of elevated ICP, coagulopathy/thrombocytopenia or use of therapeutic anticoagulation, or a history of LP complications).
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:20mg dose
Fluoxetine 20 MG Oral Tablet
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Once-daily dosing for 90 days
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Serum Sodium Concentration
大体时间:90 days following acute, ischemic stroke
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Serum Sodium Concentration was measured in mmol/L.
Hyponatremia was considered as <125 mmol/L.
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90 days following acute, ischemic stroke
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Serum Alanine Aminotransferase (ALT)
大体时间:90 days
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Hepatic impairment was measured by elevation of hepatic enzyme (serum alanine aminotransferase; ALT) of >120 U/L
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90 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Fugl-Meyer Motor Scale Score for Assessment of Motor Function After Stroke
大体时间:90 days following acute, ischemic stroke
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The Fugl Meyer motor scale is used to assess post-stroke motor recovery in stroke patients.
It is scored on a scale from 0 to 100, with lower scores indicating greater disability.
It evaluates both lower and upper extremities for motor performance: 66 points are allocated to the upper extremities, 34 to the lower extremities.
The two extremities are summed to achieve the total score.
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90 days following acute, ischemic stroke
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Montgomery-Asberg Depression Rating Scale
大体时间:90 days following acute, ischemic stroke
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10-item questionnaire used to evaluate the severity of a patient's depressive symptoms.
Each item is scored on a scale from 0 to 6, the scores are summed, and the total score (0 to 60 points) is reported.
The greater the score, the more severe the degree of depression.
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90 days following acute, ischemic stroke
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Modified Rankin Scale
大体时间:90 days following acute, ischemic stroke
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Validated instrument for measuring the degree of disability in stroke patients.
The modified Rankin Scale is based on a physicians subjective evaluation.
The scale ranges from 0, indicating perfect health, to 6, indicating that the patient is dead.
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90 days following acute, ischemic stroke
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The Patient Health Questionnaire-9 (PHQ-9) Scale for Measuring Depression
大体时间:90 days following acute ischemic stroke
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The PHQ-9 is a validated 9-point questionnaire for measuring depression symptom severity.
Each question is scored from 0-3.
Answers are summed and the total score (0 to 27) is reported.
The greater the score, the greater the severity of depression.
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90 days following acute ischemic stroke
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合作者和调查者
调查人员
- 首席研究员:Farrah J Mateen, MD, PhD、Massachusetts General Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 2018P001693
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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Fluoxetine 20 MG Oral Tablet的临床试验
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