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
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Mobile 9-hole Peg Test Time Comparison
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: Mobile Multiple Sclerosis Functional Composite (Procedure)
Outcomes
Primary Outcomes
Mobile 9-hole Peg Test Time Comparison
Time Frame: Week 6
Mobile 9HPT time will be compared to 9 HPT time for proof of calibration.
Safety of mMSFC Tally
Time Frame: 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
Time Frame: Week 6
mMSFC scores will be compared to MSFC scores for proof of calibration.
Mobile Timed Walk Test Value Comparison
Time Frame: 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
Time Frame: Week 6
Mobile PASAT3 scores will be compared to PASAT3 scores for proof of calibration.
Secondary Outcomes
No secondary outcomes reported