Phase 2a, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of the Safety, Tolerability, and Proof-of-Concept Efficacy of Lisinopril in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS), Stage 1
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mobile 9-hole Peg Test Time Comparison
研究概览
简要总结
This study aims to calibrate the Multiple Sclerosis Functional Composite (MSFC) for home implementation in a phase 2 trial of lisinopril in multiple sclerosis. In this initial stage, participants are required to travel to the study site one day a week for three weeks to complete the MSFC. They are also required to complete the MSFC at home once weekly for three weeks using remote sensing technology and video conferencing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between the ages of 18 and
- •Documented informed consent
- •Documented diagnosis of RRMS via 2010 McDonald Criteria
- •Normal blood pressure at baseline: 90-140 mmHg systolic AND 60-90 mmHg diastolic
- •Baseline score of 0-5.5 on Kurtzke's Expanded Disability Status Scale (EDSS)
- •Availability of a person in the home who is physically able and willing to steady the subject if s/he loses balance during the walk test.
排除标准
- •Hypotensive at baseline: <90 mmHg systolic or <60 mmHg diastolic
- •Hypertensive at baseline: >140 mmHg systolic or >90 mmHg diastolic
- •Bradycardia at baseline: < 50 bpm
研究组 & 干预措施
Group 1
Participants will be separated into two groups for scheduling purposes. Each group will complete the Multiple Sclerosis Functional Composite (MSFC) once weekly at the study site and once weekly at home for three weeks. They will alternate their visit dates with Group 2.
干预措施: Multiple Sclerosis Functional Composite (Procedure)
Group 1
Participants will be separated into two groups for scheduling purposes. Each group will complete the Multiple Sclerosis Functional Composite (MSFC) once weekly at the study site and once weekly at home for three weeks. They will alternate their visit dates with Group 2.
干预措施: Mobile Multiple Sclerosis Functional Composite (Procedure)
Group 2
Participants will be separated into two groups for scheduling purposes. Each group will complete the Multiple Sclerosis Functional Composite (MSFC) once weekly at the study site and once weekly at home for three weeks. They will alternate their visit dates with Group 1.
干预措施: Multiple Sclerosis Functional Composite (Procedure)
Group 2
Participants will be separated into two groups for scheduling purposes. Each group will complete the Multiple Sclerosis Functional Composite (MSFC) once weekly at the study site and once weekly at home for three weeks. They will alternate their visit dates with Group 1.
干预措施: Mobile Multiple Sclerosis Functional Composite (Procedure)
结局指标
主要结局
Mobile 9-hole Peg Test Time Comparison
时间窗: Week 6
Mobile 9HPT time will be compared to 9 HPT time for proof of calibration.
Safety of mMSFC Tally
时间窗: Week 6
Safety of remote video administration of the mMSFC will be calculated at the end of the study by calculating and comparing the instances of balance-related safety issues.
MSFC Score Comparison
时间窗: Week 6
mMSFC scores will be compared to MSFC scores for proof of calibration.
Mobile Timed Walk Test Value Comparison
时间窗: Week 6
Mobile timed walk times will be compared to 25-foot timed walk test times for proof of calibration.
Mobile Paced Auditory Serial Addition Test Score Comparison
时间窗: Week 6
Mobile PASAT3 scores will be compared to PASAT3 scores for proof of calibration.
次要结局
未报告次要终点